CRO'S LIST

CLINICAL ORGANIZATIONS IN INDIA

Accutest Research Laboratories

A-31, TTC Industrial area, Khairane MIDC, Thane,

Belapur Road, Navi Mumbai 400709 (M.S.)

Phone:             +91 22 27780718       / 19 / 20, Fax: +91 22 27780721

E-mail: business@accutest.com, accutest@vsnl.net

Website: www.accutest.com

Ace Biomed Pvt Ltd

Amar Tara Plastics Compound, Saki Vihar Road, Powai,

Mumbai 400072 (M.S.)

Phone:             +91 22 67030603       / 67024021 / 22, Fax: +91 22 67030604

E-mail: info@acebiomed.com, Website: www.acebiomed.com

Ace Biomed Pvt. Ltd.

Amar Tara Plastics Compound, Saki-Vihar Road,

Powai, Mumbai-400 072

Phone:            +91-022-6703 0603       / 6702 4021 / 22, Fax: 6703 0604

E-mail: info@acebiomed.com, Website: www.acebiomed.com

Actimus Biosciences

Varun Towers, 4th Floor, Kasturiba Marg,

Siripuram, Visakhapatnam 530003, (A.P.)

Phone:             +91-891-6672000      , 100, 200, 300. Extn: 103

Fax: +91-891-6672111 E-mail: info@actimusbio.com

Website: www.actimusbio.com

AnaZeal Analyticals & Research Pvt. Ltd.

C-404,TTC Industrial Area, Opp. JISL, MIDC,

Pawane, Navi Mumbai 400 705, (M.S.)

Phone:            +91 22 2763 3040       / 41 /42 / 43, Fax: +91 22 2763 3044

E-mail: anazeal@vsnl.net, Website: www.anazeal.com

Apothecaries Ltd.

579 Devli East Sainik Farms, New Delhi 110 062

Phone:             +91-11-24502551      , 24502552, 24502553, 2991201

Fax: +91-11-29912416, E-mail: ReachUs@Apothecaries.net

Website: www.apothecaries.net

Asian Clinical Trials (ACT)

A Division of Suven Life Sciences Ltd.,

Serene Chambers, Rd #5 Avenue7 Banjara Hills, Hyderabad 500034

Phone:             +91 40 2354 3314      , Fax: +91 40 2355 0501

Website: http://www.act-.com

Asian Clinical Trials Pvt Ltd

5/F, Serene Chambers Road No.7, Banjara Hills, Hyderabad-500 034

Phone: 5566866/23541142, Fax: 23550501

Website: www.act.com

Asiatic Clinical Research Pvt. Ltd.

169/53, 14th Main Road, 1st Block East, Jayanagar, Bangalore 560 011

Phone:             +91 (0) 80 4168 1122       / 33 / 44, Fax: +91 (0) 80 4121 3841

E-mail: info@asiaticlinical.com, website: www.asiaticlinical.com

Aurigene Discovery Technologies

Electronic City, Phase II, 39, 40 electronic City Phase II,

Housur Road, KIADB Industrial Area, Bangalore-560 100

Phone:             +91-080-28521314      , Fax: +91-080-28526285

E-mail: partnerships@aurigene.com, Website: www.aurigene.com

Avra Laboratories

Avra House, 54, Sai Enclave, Habsiguda, Hyderabad- 500 007

Phone:             +91-040- 27178571      , 27150422, Fax: 27179149, 27175605

E-mail: info@avralab.com, Website: www.avralab.com

                 

                 

Bilcare Limited

601, ICC Trade Tower, Pune-411 106

Phone:             +91 020 30257700      , Fax: 020 30257701

E-mail: mail@bilcare.com, Website: www.bilcare.com

BioAxis DNA Research Centre

#12-13-1249, 1st floor, Besides Andhra Bank, opp. Appolo Clinic,

Tarnaka Main Road, Secunderabad-500017 (A.P.)

Phone: +91-40-40180502/9247438983

E-mail: dnaresearchcentre@gmail.com, Website: www.dnares.in

Bioequivalence Study Centre

Department of Pharmaceutical Technology

Jadavpur University, Kolkata-700032

Phone:             +91(033) 2414 6967       / 6266 , Fax: +91 (033) 2414 6186

Email: tkpal_12@yahoo.com, tkpal@biostudy.in 

Website: www.biostudy.in

Bioserve Biotechnologies (I) Pvt Ltd

Lab No. 8, ICICI Knowledge Park, Genome Valley,

Turkapalli Village, Shameerpet Mandal, Hyderabad-500078

Phone:            +91-40-27178176      , Fax: +91-40-27178178

E-mail: info@bioserve.com, Website: www.bioserve.com

                 

                 

C B Patel Research Center

Bhaidas Sabhaghriha, 3rd Floor Vile Parle (W), Mumbai-400 056

Phone: 91-22-2618 0855/ 2611 9792, Fax: 91-22-2613 3400

E-mail: cbprc@svkm.ac.in, Website: www.cbprc.svkm.ac.in

Catalyst Clinical Services Pvt. Ltd.

119- State Bank Colony, G.T. Karnal Road, Delhi-110009,

Phone:            +91-11-42384005      , Telefax: +91-11-27466248

E-mail: info@catalystclinicalservices.com

Website: www.catalystclinicalservices.com

Chembiotek Research International

Block BN, Sector V, Salt Lake City, Kolkata-700091

Phone: +91-033-23673151/52 , Fax: +91-033-23673058

E-mail: research@chembiotek.com, Website: www.chembiotek.com

Clinexa [Site Management Organization (SMO)]

504 "A" Wing, Galleria Building, Hiranandani Business Park,

Powai, Mumbai 400076. Phone:             +91-22-25717086     

Fax: +91-22-25717087, E-mail: info@clinexa.com

Clinigene International (BioCon)

20th K M Hosur Road, Electronics City, Bangalore-560 100

Phone:             +91 80 2808 2808      , E-mail: Contact.us@bioconfoundation.com

Website: www.biocon.com

Clinigene International Limited

"Clinigene House", Tower 1, Semicon Park, Electronic City, Phase II,

Hosur Road, Bangalore-560100

Phone:             + 91 80 2808 2780      , Fax: + 91 80 2852 2989

E-mail: BD@clinigeneintl.com, Website: www.clinigeneintl.com

Clininvent Research Pvt. Ltd.

A-103, Everest Chambers, Marol Naka, Andheri-Kurla Road,

Andheri (E), Mumbai-400 059. Phone: + 91-22-6781 8600

Fax: + 91-22-6781 870, Email: arunbhatt@clininvent.com

Website: www.clininvent.com

Clininvent Research

A-302, Everest Chambers, Marol Naka, Andheri-Kurla Road,

Andheri (E), Mumbai, (M.S.) 400 059. Phone:             + 91-22-6781 8600     

Fax: + 91-22-6781 8701, E-mail: arunbhatt@clininvent.com

Website: www.clininvent.com

CLINiREACH Clinical Services

Origin life sciences & Medicare Pvt. Ltd

Bangalore

E mail: info@clinireach.org, Website: www.clinireach.org

Clinsys Clinical Research, Ltd.

C-46, Sector 62, Noida-201307, UP

Phone:             +91 120 4364000      , Fax: +91 120 2404336

Website: http://clinsys.com

ClinTec International

104, II Cross Ramaiah Reddy Layout, Benson Cross Road,

Benson Town, Bangalore, Karnataka 560046

Phone:             +91-80-23638360      , Fax: +91 (0) 80 23545436

Website: www.clintec.com

Clintech Research Pvt. Ltd.

Biotechnology Park, Sector-G, Jankipuram, Lucknow, UP 226021

Phone:             +91 (522) 4045207      , Fax: +91 (522) 2452954

Email info@clintechresearch.com

Clintrac International Pvt. Ltd

IIIrd Floor, East II, Vydehi Hospital, #82,

IPIP Area, Whitefield Road, Bangalore-066

Phone:             +91-80-51157443      , Fax: +91 80 4115 7442

E-mail: info@clintracinternational.com

Website: www.clintracintl.org

Cqua Research International Inc.

12-13-478, Avantika, St. No. 1, Taranaka, Secunderabad-500 017

Phone: +919848268980/            +919391381131      , Fax: +91-40-40180912

E-mail: info@cquaint.com, Website: www.cquaint.com

                 

                 

D2L Pharma Research Solutions

#1615, 5th Main, E Block, AECS Layout, Kundalahalli,

Bangalore-560 037. Phone: +91-80-4205 0650 / 4205 0651 / 4205

Fax: +91-80-41534831, Email: info@d2lpharma.com 

Website: http://www.d2lpharma.com

Darsan Clinica Life Sciences Pvt. Ltd.

8b-4 th Floor, Reliance Fresh Building, Vengalrao Nagar,

Hyderabad-500038. Phone:             +91-40-64580666      ,             +91-40-64580667      

Fax: +91-40 23714159, E-mail: info@darsanclinica.com

Website: http://darsanclinica.com/

Dr Lal PathLabs Pvt Ltd

Eskay House, 54, Hanuman Road, New Delhi Delhi 110 001

Phone:            +91 11 30403210      , 23366569, 23342046

E-Mail: lalpathlabs@lalpathlabs.com

Website: www.lalpathlabs.com

Dr Reddy's Laboratories Limited

7-1-27, Ameerpet, Hyderabad 500016 (A.P.)

Phone:             +91-40-23731946      , Fax: +91-40-23731955

E-mail: webmaster@ddreddys.com,  Website: www.drreddys.com

                 

                 

Eli Lilly and Company (India) Pvt. Ltd

Plot # 92, Sector 32, Institutional Area,

Gurgaon-122001Haryana,

Tel :             +91-124-2823000      ,01

Fax : +91-124-2823012, 13

Email : lillyindia@lilly.com 

Website: www.lillyindia.co.in

                 

                 

Fermish clinical technologies pvt. Ltd.

D-115, Okhla Industrial Area, Phase-I, New Delhi-110020,

Phone:            +91 11 3088 5160      , Fax: +91 11 3088 5169

Mail: contact@fermish.com, Website: www.fermish.com           

                 

                 

GCTRO Health Pvt. Ltd

Pocket A-1, Plot No.-7, Sector-8, Rohini, Delhi-110085

Phone:            +91-9811126011     

GVK Biosciences Pvt Ltd

#210, My Home Tycoon, 6-3-1192, Kundanbagh Begumpet,

Hyderabad 500016 (A.P.). Phone:+91 40 66929999, Fax: 66929900

E-Mail: bdcrd@gvkbio.com, Website: www.gvkbio.com

                 

                 

Helix Research Center Pvt. Ltd.

18-81, Kamala Nagar, Chaitanyapuri 'X' Roads, Dilsukh Nagar,

Hyderabad-60, A.P, . E-mail: admin@helixresearchcenter.com

Website: http://helixresearchcenter.com

                 

                 

iGATE Clinical Research International

101-102, Alpha, Hiranandani Gardens, Powai, Mumbai 400 076,

Phone:             +91-22-56971900      , Fax: +91-22-56971920

E mail: infoicri@igate.com, Website: www.igate.com/icri

INTOX Private

375, Urawade, Pirangut Taluka Mulshi District - Pune 412 108

Email: intox@vsnl.com 

Website: www.intoxlab.com

                 

                 

Jubilant Clinsys

C-46, sector -62, Noida - 201 301

Phone:             +91-124- 2404333       Fax : 2516627

E-mail : abhinav_rahul@jubl.com, 

Website: www.jubilantorganosys.com 

                 

                 

Kendle India

23-24, Vatika Business Center, 2nd floor,

First India Place, Block B, Mehrauli-Gurgaon Road, Sushant Lok-1 Gurgaon-02 U.P.

Phone:             +91-124-506 7071      

Fax: +91-124-502 8934, 502 8800

Email: doshi.bharat@kendle.com 

Website: www.kendle.com        KPS Clinical Services Pvt. Ltd.

ECO-69, II Floor, Building Material Market, Ecotech II,

Opp. Moserbaer, Greater Noida, G.B Nagar, U.P. -Pincode-201306

Phone: 0120- 4231720,4231721, M: 09873038019, 09873022365

Fax:0120-4213840, E-mail: contact@kpsclin.com, info@kpsclin.com 

Website: www.kpsclin.com

                 

                 

Lambda Therapeutic Research Ltd

42 Premier House 1, Bodakdev, Sarkhej Gandhinagar Highway,  Ahmedabad 380054

Phone:             91-79-2685 3995      , 2685 3441,

Fax: 91-79-2684 0079

Email: ahmedabad@lambda-cro.com

Website: www.lambda-cro.com

Lotus Labs Pvt. Ltd.,

# 07, Jasma Bhavan Road, Millers Tank Bed Area,

Opp. Guru Nanak Bhavan, Vasanth Nagar, Bangalore 560052

Phone:             +91 80 22370912       / 13 / 14 / 15, Fax: +91 80 22370911

Website: www.lotuslabs.com

Lambda Therapeutic Research Ltd.

Near Gujarat High Court, S. G. Highway, Gota, Ahmedabad 380061

Phone:             +91-79-40202020      , Fax: +91-79-40202021

Email us for Business Inquiry: business@lambda-cro.com

Website: www.lambda-cro.com

                 

                 

Manipal Acunova

Manipal towers 14, Airport Road, Bangalore, Karnataka 560100

Phone: +91-80-2521 7617/18, Fax: +91-80-25217619

E-mail: bd.asia@ecronacunova.com, Website: www.acunovalife.com

Max Neeman International

Max House, GF-1, Dr. Jha Marg, Okhla, New Delhi-110020

Phone:             +91 11 26322816                   +91 11 2632 2824      , Mobile:             +91 9810490456      

Fax: +91 11 26322846, Email id: rrazdan@neemanasia.com

Website: http://www.neeman-medical.com

Mayfair Clinical Education and Research Center

Mohan Mill Compund, Behind Fiat Fort Point,

Ghodbunder Road, Thane, (M.S.) 400607

Ph.:             +91-22-2589 5856      , Fax: +91-22-2589 5854

Email: info@mayfaircro.com, Website: www.mayfaircro.com

Medclin Research

IPHMR Building, 318/1B Prantik Pally, Kolkata 700107

Phone:             +91 33 2442 5433      , Mob.             +919831075734      ,             +919831395392     

Fax: +91 33 2442-5435, Cell No.-0 9831075734.

E-mail Id-medclin@vsnl.net, Website: http://www.medclinsearch.com/

Merit Medical & Allied Sciences Pvt Ltd (SMO)

1/1A 100ft Road, U R Nagar, Anna Nagar Western Extension,

Chennai, 600 101. Phone: + 91 44 6462 7611 / 7622

Fax: + 91 44 2615 4426, E-mail: info@meritclinicalresearch.in 

Website: http://meritclinicalresearch.in/

Metropolis Clinical Laboratories

Plot No.250D, Udyog Bhavan, Hindi Cycle Marg, Worli, Mumbai-30

Phone:             +91-22-6650 5555      , Fax: +91-22-66622080

E-mail: support@metropolis.com, Website: www.metropolis.com 

                 

                 

Neeman Medical International (Asia)

Max House 1, Dr.Jha Marg Okhla, New Delhi 110 020

Phone:             +91 11 26322816      , 4077 2100, Fax: +91 11 2632 284

Email: rrazdan@neemanasia.com

Website: www.neeman-medical.com

NexusCRO

“Anuj”, Plot No 45, 1st Floor Mumbai-Pune Highway,

Near D.Y. Patil Stadium, Sector-13, Nerul (E) New Mumbai-400 706

Board Lines: +91-22-27714204/4205/4207

E-mail: info@nexuscro.com, Website: http://www.nexuscro.com/

Nirup Clinical Research (NCR)

401, Hill View Industrial Estate, Amrut Nagar, LBS Marg,

Ghatkopar West, Mumbai 86.

E-mail: info@ncr-.com, Website: http://www.ncr-.com

                 

                 

Omnicare Clinical Research

#208 Midford House, Midford Garden Road, Off M G Road, Bangalore,

Karnataka 560 001

Phone:             91 80 2509 5585      , 2509 5588

E-mail: Investigators@omnicarecr.com 

Web: www.omnicarecr.com        

                 

                 

Phoenix Clinical Research

B-105, Sethi Colony, Agra Road, Jaipur-302004, Rajasthan,

E-mail: contact@phoenixclinicalresearch.com

Website: http://www.phoenixclinicalresearch.com

PPD Pharmaceutical Development

406 Acropolis, Military Road, Marol Andheri (E), Mumbai-400 059

Phone:             +91 22 25712900      , Website: www.ppdi.com

Progressive Life Sciences

903, Arunachal building, Barakhamba Road, New Delhi.

Phone:             +91-9968295224      , Fax- +91-11-23321509, (623) 433-1980

info@progressivelifesciences.com

Website: www.progressivelifesciences.com

                 

                 

Quartesian

#230, 1st Cross, 38th main, BTM II Stage, Bangalore-560076

Phone:            +91-80-32914653      , Website: www.quartesian.com

Quintiles Spectral Private

3 Ashoknagar Bungalows, Behund Sundarvan Satellite Road,

Ahmedabad, Gujurat 380 015

Phone:             +91-79-26923303      , Fax: +91-79-26924311

Quintiles Technologies Pvt. Ltd.

Brigade South Parade, 3rd Floor, 10, M.G Road, Bangalore-380 015

Phone:             +91-80-66552100      , Fax: +91-80-41156255

E-mail: clinical.info@quintiles.com, Website: www.quintiles.com

                 

                 

Ranbaxy Laboratories Limited

Plot 90, Sector 32, Gurgaon-122001 (HR)

Phone:             +91- 124-4135000      , Fax: +91-124-4135001

E-mail: ramesh.adige@ranbaxy.com

Website: www.ranbaxy.com

Reametrix

50-B, II Phase, Peenya Industrial Area, Bangalore 560058

Phone: +91- 80-28378693 /28378695

E-mail: info@reametrix.com, Website: www.reametrix.com

Reliance Clinical Research Services

DAKC-LSC, R-282, TTC Areas of MIDC, Thane Belapur road

Rabale, Navi Mumbai, (M.S.) 400701

Phone:             +91-22-67678000      , Fax: +91-22-67678299

E-mail: ClinicalResearch.Enquiry@relclin.com, Web: www.relclin.com

Rhenium Clinical Research Pvt Ltd

1A/8 2nd main, Sripuram, Chakravarty Iyengar Layout,

Sheshadripuram, Bangalore 560020

Phone:            (91)-80-2346 3651      , Fax: (91)-80-2346 3659

E-mail: info@rheniumresearch.com

Website: http://www.rheniumresearch.com/

Roche Scientific Company (i) Pvt. Ltd.

B/2, Amarchand Mansion, 1st Floor, Madam Cama Road,

Mumbai 400039. Phone:             +91-22-22880693      , Fax: +91-22-22021204

E-mail: girish.telang@roche.com, Website: www.roche.com 

                 

                 

Sanofi-Aventis (Aventis Pharma Limited)

Aventis House, 54-A, Sir Mathurdas Vasanji Road, Andheri (E),

Mumbai - 400 093

Phone: 022 28278000; Fax: 022 28370939

Website: www.aventispharmaindia.com

Sipra Labs Pvt. Ltd.

407, Nilgiri, Block Aditya Enclave Ameerpet, Hyderabad, 38 A.P.

Phone: +91-40-23734720/23746873/874

Fax: +91-40-23746871

E-mail : sipra@sipralabs.com 

Website: www.sipralabs.com

                 

                

Clinical Interview Questions

What is the therapeutic area you worked earlier?

There are so many diff. therapeutic areas a pharmaceutical company can work on and few of them include, anti-viral (HIV), Alzheimer’s, Respiratory, Oncology, Metabolic Disorders (Anti-Diabetic), Neurological, Cardiovascular. Few more of them, include…

Central nervous system

Neurology

Gastroenterology

Ophthalmology

Orthopedics and pain control

Pulmonary

Vaccines

Dermatology

Gene therapy

Immunology etc

What are your responsibilities?

Some of them include; not necessarily all of them….

· Extracting the data from various internal and external database (Oracle, DB2, Excel spreadsheets) using SAS/ACCESS, SAS/INPUT.

· Developing programs in SAS Base for converting the Oracle Data for a phase II study into SAS datasets using SQL Pass through facility and Libname facility.

· Creating and deriving the datasets, listings and summary tables for Phase-I and Phase-II ofclinical trials.

· Developing the SAS programs for listings & tables for data review & presentation including ad-hoc reports, CRTs as per CDISC, patients listing mapping of safety database and safety tables.

· Involved in mapping, pooling and analysis of clinical study data for safety.

· Using the Base SAS (MEANS, FREQ, SUMMARY, TABULATE, REPORT etc) and SAS/STAT procedures (REG, GLM, ANOVA, and UNIVARIATE etc.) for summarization, Cross-Tabulations and statistical analysis purposes.

· Developing the Macros at various instances for automating listings and graphing of clinical data for analysis.

· Validating and QC of the efficacy and safety tables.

· Creating the Ad hoc reports using the SAS procedures and used ODS statements and PROC TEMPLATE to generate different output formats like HTML, PDF and excel to view them in the web browser.

· Performing data extraction from various repositories and pre-process data when applicable.

· Creating the Statistical reports using Proc Report, Data _null_ and SAS Macro.

· Analyzing the data according to the Statistical Analysis Plan (SAP).

· Generating the demographic tables, adverse events and serious adverse events reports.

Can you tell me something about your last project study design?

If the interviewer asked you this question, then you need to tell that your current project is on a phase-1 study (or phase-2/Phase-3). You also need to tell about the name of the drug and the therapeutic area.  Here are some more details you need to lay down in front of him…

a) Is it a single blinded or double-blinded study?

b) Is it a randomized or non-randomized study?

c) How many patients are enrolled.

d) Safety parameters only (if it is a phase-1)

e) Safety and efficacy parameters if the study is either Phase-2,3or 4.

To get the all these details... visit http://www.clinicaltrials.gov/ .

How many subjects were there?

Subjects are nothing but the patients involved in the clinical study.

Answer to this question depends on the type of the study you have involved in.

If the study is phase1 answer should be approx. between 30-100.

If the study is phase2 answer should be approx. between 100-1000.

If the study is phase3 answer should be approx. between 1000-5000.

Note: These are just typical and not exact numbers.

How many analyzed data sets did you create?

Again it depends on the study and the safety and efficacy parameters that are need to determined from the study. Approx. 20-30 datasets is required for a study to get analyzed for the safety and efficacy parameters. Here is some ex. of the datasets.

DM (Demographics),

MH (Medical History),

AE (Adverse Events),

PE (Physical Education),

EG (ECG),

VS (Vital Signs),

CM (Concomitant Medication),

LB (Laboratory),

QS (Questionnaire),

IE (Inclusion and Exclusion),

DS (Disposition),

DT (Death),

SV (Subject Visits),

SC (Subject Characteristics),

CO (Comments),

EX (Exposure),

PC (Pharmacokinetic Concentrations),

PP (Pharmacokinetic Parameters),

TI (Therapeutic Intervention),

and other Supplementary datasets like

SUPPCM, SUPPEX, SUPPLB, SUPPMH, SUPPXT, SUPPEG etc.

How did you create analyzed data sets?

Analysis datasets are nothing but the datasets that are used for the statistical analysis of the data. Analysis datasets contains the raw data and the variables derived from the raw data. Variables, which are derived for the raw data, are used to produce the TLG’s of the clinicalstudy. The safety as well as efficacy endpoints (parameters) dictate the type of the datasets are required by the clinical study for generating the statistical reports of the TLG’s. Sometimes the analysis datasets will have the variables not necessarily required to generate the statistical reports but sometimes they may required to generate the ad-hoc reports.

Refer also http://www2.sas.com/proceedings/forum2008/207-2008.pdf to get the complete info about creation of datasets:

How many tables, listings and graphs?

Can be in between 30-100 (including TLG’s)

What do you mean by treatment emergent and treatment emergent serious adverse events?

Treatment emergent adverse events and Treatment emergent serious adverse events are nothing but the adverse events and serious adverse events which were happened after the drug administration or getting worsen by the drug, if patients are already having those adverse events before drug administration.

Can you explain little bit about the datasets?

DEMOGRAPHIC analysis dataset contains all subjects’ demographic data (i.e., Age, Race, and Gender), disposition data (i.e., Date patient withdrew from the study), treatment groups and key dates such as date of first dose, date of last collected Case Report Form (CRF) and duration on treatment. The dataset has the format of one observation per subject.

LABORATORY analysis dataset contains all subjects’ laboratory data, in the format of one observation per subject per test code per visit per accession number. Here, we derive the study visits according to the study window defined in the SAP, as well as re-grade the laboratory toxicity per protocol. For a crossover study, both the visit related to the initial period and as it is related to the beginning of the new study period will be derived. If the laboratory data are collected from multiple local lab centers, this analysis dataset will also centralize the laboratory data and standardize measurement units by using conversion factors.

EFFICACY analysis dataset contains derived primary and secondary endpoint variables as defined in the SAP. In addition, this dataset can contain other efficacy parameters of interest, such as censor variables pertaining to the time to an efficacy event. This dataset has the format of one record per subject per analysis period.

SAFETY can be categorized into four analysis datasets:

VITAL SIGN analysis dataset captures all subjects’ vital signs collected during the trial. This dataset has the format of one observation per subject per vital sign per visit, similar to thestructure for the laboratory analysis dataset.

ADVERSE EVENT analysis dataset contains all adverse events (AEs) reported including serious adverse events (SAEs) for all subjects. A treatment emergent flag, as well as a flag to indicate if an event is reported within 30 days after the subject permanently discontinued from the study, will be calculated. This dataset has a format of one record per subject per adverse event per start date. Partial dates and missing AEs start and/or stop dates will be imputed using logic defined in the SAP.

MEDICATION analysis dataset contains the subjects’ medication records including concomitant medications and other medications taken either prior to the beginning of study or during the study. This dataset has a format of one record per subject per medication taken per start date. Incomplete and missing medication start or stop dates will be imputed using instructions defined in the SAP.

SAFETY analysis dataset contains other safety variables, whether they are defined in the SAP or not. The Safety analysis dataset, similar to Efficacy analysis dataset in structure, consists of data with one record per subject per analysis period to capture safety parameters for all subjects.

It is crucial to generate analysis datasets in a specific order, as some variables derived from one particular analysis dataset may be used as the inputs to generate other variables in other analysis datasets. For example, the time to event variables in the efficacy and safety analysis datasets are calculated based on the date of the first dose derived in the demographic analysis dataset.

Analysis datasets are generated in sequence

(Safety Datasets)

Demographic _______Laboratory __________Efficacy

Vital Sign

Adverse Event

Concomitant Medications

Source:www.thotwave.com/Document/.../GlobalArch/SUGI117-30_GlobalArchitecture.pdf

What is your involvement while using CDISC standards? What is mean by CDISC where do you use it?

CDISC is nothing but an organization (Clinical Data Interchange Standards Consortium), which implements industrial standards for the pharmaceutical industries to submit the clinical data to FDA.

There are so many advantages of using CDISC standards: Reduced time for regulatory submissions, more efficient regulatory reviews of submission, savings in time and money on data transfers among business.

CDISC standards is used in following activities:

Developing CRTs for submitting them to FDA to get an NDA.

Mapping, pooling and analysis of clinical study data for safety.

Creating the annotated case report form (eCRF) using CDISC-SDTM mapping.

Creating the Analysis Datasets in CDISC and non-CDISC Standards for further SAS Programming.

What do you mean when you say you created tables, listings and graphs for ISS and ISE?

http://studysas.blogspot.com/2008/09/what-you-should-know-about-issise-isr.html

How do you do data cleaning?

It is always important to check the data we are using- especially for the variables what we are using. Data cleaning is critical for the data we are using and preparing.

I use Proc Freq, Proc SQL, MEANS, UNIVARIATE etc to clean the data.

I will use Proc Print with WHERE statement to get the invalid date values.

Source: http://books.google.com/books?id=dyzAV8Miv5cC&dq=data+cleaning+techniques+in+SAS&printsec=frontcover&source=bl&ots=nDNyuK3tdi&sig=hWCujflLK53KAA7no8V_c4eu_6I&hl=en&sa=X&oi=book_result&resnum=9&ct=result#PPA32,M1

Can you tell me CRT's??

Creating Case Report Tabulations (CRTs) for an NDA Electronic Submission to the FDA

http://www2.sas.com/proceedings/sugi25/25/ad/25p031.pdf

ABSTRACT:The Food and Drug Administration (FDA) now strongly encourages all new drug applications (NDAs) be submitted electronically. Electronic submissions could help FDA application reviewers scan documents efficiently and check analyses by manipulating the very datasets and code used to generate them.The potential saving in reviewer time and cost is enormous while improving the quality of oversight. In January 1999, the FDA released the Guidance for Industry: Providing Regulatory Submissions in Electronic Format – NDAs. As described, one important part of the application package is the case report tabulations (CRTs), now serving as the instrument for submitting datasets. CRTs are made up of two parts: first, datasets inSAS® transport file format and second, the accompanying documentation for the datasets. Herein, we briefly review the content and conversion of datasets to SAS transport file format, and then elaborate on the code that makes easy work of theaccompanying dataset documentation (in the form of data definition tables) using the SAS Output Delivery System (ODS). The intended audience is SAS programmers with an intermediate knowledge of the BASE product used under any operating system and who are involved in the biotechnology industries.

Where do you use MEdDra and WHO? Can you write a code? How do you use it?

What is MedDRA?

The Medical Dictionary for Regulatory Activities (MedDRA) has been developed as a pragmatic, clinically validated medical terminology with an emphasis on ease-of-use data entry, retrieval, analysis, and display, with a suitable balance between sensitivity and specificity, within the regulatory environment. MedDRA is applicable to all phases of drug development and the health effects of devices. By providing one source of medical terminology, MedDRA improves the effectiveness and transparency of medical product regulation worldwide.

MedDRA is used to report adverse event data from clinical trials, as well as post-marketing and pharmacovigilance.

What are the structural elements of the terminology in MedDRA?

The structural elements of the MedDRA terminology are as follows:

SOC (System Orgon Class) - Highest level of the terminology, and distinguished by anatomical or physiological system, etiology, or purpose

HLGT( High Level Group Term) – Subordinate to SOC, superordinate descriptor for one or more HLTs

HLT (High Level Term) – Subordinate to HLGT, superordinate descriptor for one or more PTs

PT (Preferred Term) – Represents a single medical concept

LLT (Lower Level Term) – Lowest level of the terminology, related to a single PT as a synonym, lexical variant, or quasi-synonym (Note: All PTs have an identical LLT).

In what format is MedDRA distributed?

MedDRA is distributed in sets of flat ASCII delimited files. There is a different set of files for each available language. The Czech translation is distributed in UTF-8 format. For detail information as to file names, data record scheme, and record layout, sees the MedDRA ASCII and Consecutive Files Documentation document, which can be downloaded from the MedDRA MSSO Web site. MedDRA is delivered in text file format. As of MedDRA Version 11.1, the total size of all ASCII files for the English version is 12,459KB.

Source: http://www.meddramsso.com/MSSOweb/faq/meddra.htm#What_is_MedDRA

THE WHODRUG DICTIONARY:

The WHODrug dictionary was started in 1968. The dictionary contains information on both single and multiple ingredient medications. Drugs are classified according to the type of drug name being entered, (i.e. proprietary/trade name, nonproprietary name, chemical name, etc.). At present, 52 countries submit medication data to the WHO Collaborating Center, which is responsible for the maintenance and distribution of the drug dictionary. Updates to the dictionary are offered four times per year.

Source: http://ssc.utexas.edu/docs/sashelp/sugi/24/Coders/p108-24.pdf

What do you mean by used Macro facility to produce weekly and monthly reports?

The SAS macro facility can do lot of things and especially it is used to…

• reduce code repetition

• increase control over program execution

• minimize manual intervention

• create modular code.

Source: http://www.gasug.org/papers/DemystifyingMacro_Fecht.pdf

And also Visit http://instruct1.cit.cornell.edu/courses/econ321/public_html/sasinfo/macro.html

to get more info about macro facility.

How did you validate table’s, listings and what are the other things you validated?

First, the output from the listing needs to be read into a SAS data set. Next, the validation results need to be calculated (you need to do this anyway) and then turned into a SAS data set with the same layout and properties as the one created from the original output. Last, SAS compares the original versus validation data sets by using PROC COMPARE. The results are concise, quick, accurate and 100% complete. We have to use the same procedure to validate the Tables.

Source: http://www.lexjansen.com/pharmasug/2001/proceed/techtech/tt02_guttadauro.pdf

We will also validate graphs made in SAS… but to do that we need to use SAS/GRAPH Network Visualization Workshop and using it we can validate graphs made with SAS automatically as well as manually.

Did you see anywhere that. Patient is randomized to one drug and the patient is given another drug? if you get in which population would you put that patient into?

I will consider that patient in the group of the drug that he was given. Before I do anything, I will make sure it is a data entry error or patient is actually given the other drug. 

What would you do if you had to pool the data related to one parallel study and one cross over study?

Say If you have a same subject in two groups taking two different drugs.. and If you had to pool these two groups how would you do it?

This situation arises when the study is a cross over design study. I would consider the same patient as two different patients of each treatment group.

What are the phases you are good at?

Phase-I,II and III.

How would you transpose dataset using data step?

Using Proc Transpose Procedure.

Proc transpose data=old out=new prefix=DATE;

var date;

by name;

run;

The prefix= option controls the names for the transposed variables (DATE1, DATE2, etc.) Without it, the names of the new variables would be COL1, COL2, etc.

Actually, proc transpose creates an extra variable, _NAME_, indicating the name of the transposed variable. _NAME_ has a value of DATE on both observations. To eliminate the extra variable, modify a portion of the proc statement:

out=new (drop=_name_);

The equivalent data step code using arrays could be:

data new (keep=name date1-date3);

set old;

by name;

array dates {3} date1-date3;

retain date1-date3;

if first.name then i=1;

else i + 1;

dates{i} = date;

if last.name;

run;

This program assumes that each name has exactly three observations. If a name had more, the program would generate an error message when hitting the fourth observation for that name. When i=4, this statement encounters an array subscript out of range:

dates{i} = date;

source: http://sugme.org/papers/paper.rtf

If some patient misses one lab how would you assign values for that missing values?? Can you write the code?

Same answer as the below question….

How do you deal with missing values?

Whenever SAS encounters an invalid or blank value in the file being read, the value is defined as missing. In all subsequent processes and output, the value is represented as a period (if the variable is numeric-valued) or is left blank (if the variable is character-valued).

In DATA step programming, use a period to refer to missing numeric values.

For example, to recode missing values in the variable A to the value 99, use the following statement:

IF a=. Then a=99;

Use the MISSING statement to define certain characters to represent special missing values for all numeric variables. The special missing values can be any of the 26 letters of the alphabet, or an underscore. In the example below, the values 'a' and 'b' will be interpreted as special missing values for every numeric variable.

MISSING a b ;

Source; http://ssc.utexas.edu/consulting/answers/sas/sas33.html

Did you ever create efficacy tables?

Yes, I have created Efficacy tables. Efficacy tables are developed to get an the information about primary objectives/parameters of the study.

What is the primary and secondary end point in your last project?

Primary and secondary endpoints of the clinical trial conducted is given under the SAP. You can download the sample protocol as well as trial SAP from my blog (http://www.studysas.blogspot.com/ ) or else go to http://www.clinicaltrials.gov/ , and then type the name of pharmaceutical company, it will give you the list of clinical trials conducted by that company, if you just click on any one study, you will be able to see the primary and secondary objectives and all other details.

What are the stat procedures you used?

ANOVA, CATMOD, FREQ, GLM, LIFEREG, LIFETEST, LOGISTIC, NPAR1WAY, REG, TTEST, UNIVARIATE, MEANS, SUMMARY etc

Tell me something about proc mixed? (Sometimes they may ask you to write the syntax)Syntax: http://ftp.sas.com/samples/A55235

PROC MIXED is a generalization of the GLM procedure in the sense that PROC GLM fits standard linear models, and PROC MIXED fits the wider class of mixed linear models. Both procedures have similar CLASS, MODEL, CONTRAST, ESTIMATE, and LSMEANS statements, but their RANDOM and REPEATED statements differ (see the following paragraphs). Both procedures use the nonfull-rank model parameterization, although the sorting of classification levels can differ between the two. PROC MIXED computes only Type I -Type III tests of fixed effects, while PROC GLM offers Types I - IV. The RANDOM statement in PROC MIXED incorporates random effects constituting the vector in the mixed model. However, in PROC GLM, effects specified in the RANDOM statement are still treated as fixed as far as the model fit is concerned, and they serve only to produce corresponding expected mean squares.

Source: http://www.otago.ac.nz/sas/stat/chap41/sect4.htm

What would you do, if you have to use data step functions in macro definition? Can you use all the functions in data step in macro definition?

Yes.

If I have a dataset with different subjid's and each subjid has many records? How can I obtain last but one record for each patient?

Syntax:

Proc sort data=old;

By subjid;

Run;

Data new;

Set old;

By subjid;

If first.subjid;

Run;

Or

proc sort data=old out=new nodupkey;

by subjid;

run;

Can you get some value of a data step variable to be used in any other program you do later in the same SAS session? How do you do that?

Use a macro… with a %PUT statement.

What would you do if you have to access previous records values in current record?

Using ampersand sign…. &var.

What is a p value? Why should u calculate that? What are the procedures you can use for that?

If the p-value were greater than 0.05, you would say that the group of independent variables does not show a statistically significant relationship with the dependent variable, or that the group of independent variables does not reliably predict the dependent variable. Note that this is an overall significance test assessing whether the group of independent variables, when used together reliably predicts the dependent variable, and does not address the ability of any of the particular independent variables to predict the dependent variable. Using the PROC FREQ, PROC ANOVA, PROC GLM  and  PROC TTEST we cal calculate the p-value.

What do you usually do with proc life test?

PROC LIFETEST is used to obtain Kaplan-Meier and life table survival estimates (and plots). Using a strata statement in Proc Lifetest, which compare survival estimates for different groups.

Can you get survival estimates with any other procedures?

PROC LIFEREG and PROC PHREG can also be used to get the survival estimates along with PROC LIFETEST.

Can you write a code to get the survival estimates?

proc lifetest data=data method=km outsurv=newdata;

time survival*status(0);

strata study;

run;

What is the difference between stratum and by statement in Proc Lifetest?

You can specify a BY statement with PROC LIFETEST to obtain separate analyses on observations in groups defined by the BY variables.

The BY statement is more efficient than the STRATA statement for defining strata in large data sets. However, if you use the BY statement to define strata, PROC LIFETEST does not pool over strata for testing the association of survival time with covariates nor does it test for homogeneity across the BY groups.

The STRATA statement indicates which variables determine strata levels for the computations.

The strata are formed according to the non-missing values of the designated strata variables. The MISSING option can be used to allow missing values as a valid stratum level.

Source: http://www.math.wpi.edu/saspdf/stat/chap37.pdf

Which procedure do you usually use to create reports?

Proc Report, proc Tabulate and Data _null_.

What do you do, if you had to get the column names and some title in every page of your report when you create it using data_null_?

Give your data _null_ titles the "proc print" and "proc report" feel

The more you can make your "data _null_" behave like "proc print" or "proc report", when it comes to titles, the better. If the "byline" option is set then put out a dashed "byline". If not, then don't. Does your "by" variable have a label? If so, then your dashed byline should have the text of your variable label in it on the left of the equals sign. If the variable has no label then it should just be the variable name. If that's the way "proc report" or "proc print" does it then do it that way with your "data _null". Get it to interface with #byval and #byvar entries if they exist. Give people the feel that "data _null_" reporting is no different to using "proc print" or "proc report" and you will have less opposition to your "data _null_" reports. How you do this is already in those two pages. You are going to find yourself in a situation whereby you really must do the report using data _null_ but other people are not comfortable with it because they feel it is "too different" than using "proc report". The more you can give it the same feel, the more easily you can dip into "data _null_" when you have to without people worrying.

Source: http://www.datasavantconsulting.com/roland/nulltech.html

How do you use the macro which is created by some other people and which is in some other folder other than SAS?

With SAS Autocall library using the SAS Autos system.

Can you tell me something regarding the macro libraries?

Macro libraries are the libraries, which stores all the macros required for developing TLG’s of the clinical trial. These are very are necessary in controlling and managing the macros. With the help of a %INCLUDE statement; the stored macros in the macro library can be automatically called.

Can you show me how the efficacy table looks like?

http://studysas.blogspot.com/2008/08/tlf-samples.html

Can you show me how the safety table looks like?

http://studysas.blogspot.com/2008/08/tlf-samples.html

Did you use ODS?

Yes, I have used the ODS(Output Delivery System), which normally used to make the output from the Tables, Listings and graphs looks pretty. ODS creates the outputs in html, pdf and rtf formats.

General syntax:

Start the output with:

Ods output---format ;

SAS statements……………..

…..

Ods output-format close;

Your resume says you created HTML, RTF, PDF? Why you had to create three?? Can you tell me in specific why each form is used?

There are several ways of format to create the SAS output.

To publish or to place the output on the Internet we need to create the output in HTML format, by converting the output into HTML files. We generally create the SAS output in RTF, because the RTF can be opened in Word or other word processors. If we need to send the printable reports through email, we need to create the output in PDF. PDF output is also needed when we send documents required to file an NDA to FDA.

What are the graphs you created?

Survival estimate graphs.

What are the procedures you used to create them?

PROC LIFETEST, PROC GCHART, PROC GPLOT, PROC GREPLAY etc.

Can you generate statistics using Proc SQl?

Yes, we can generate the statistics like N, Mean, Median, Max, Min, STD & SUM using PROC SQL. But SQL procedure cannot calculate all the above statistics by default, as it is the case with PROC MEANS.

When do you prefer Proc SQl? Give me some situation?
The SQL procedure supports almost all the functions available in the DATA step for the creation of data as well as the manipulation of the data.

When we compare the same result, obtained from SQL and with the Data step, PROC SQL requires less code and, more importantly it requires less time to execute the code.

How do you delete a macro variable?

If the macro variable is stored in the library then it is a easy to delete it. Multiple variables may be deleted by placing the variable names in the DELETE statement:

Why do you have to use proc import and proc export wizards? Give me the situation?

Safety Datasets Examples:

Following 16 datasets are the examples for safety datasets.........

·                      

Adverse Events,

·                      

(Prior and) Concomitant Medications,

·                      

Comments,

·                      

Demographics,

·                      

Disposition/End of Study,

·                      

Drug Accountability,

·                      

ECG,

·                      

Exposure,

·                      

Inclusion and Exclusion Criteria,

·                      

Lab,

·                      

Medical History,

·                      

Physical Examination,

·                      

Protocol Violations,

·                      

Subject Characteristics,

·                      

Substance Use, and

·                      

Vital Signs.