CAREER IN CLINICAL RESEARCH

What you should know about Career in Clinical Research, but could not find

a proper guide / mentor…

Umakanta Sahoo, MBA, PhDChiltern International, Mumbai

03 June 2006

Why A Career in Clinical Research

• Sunrise Industry, Booming Market• Huge Demand & Supply Gap, Easy Entry• White Collared, Knowledge Intensive Job vis-à-vis

Boring Sales/Marketing/Production Jobs & Unstable and Uncertain Clinical Practice

• Good Career Prospects• Quickies (quick money, growth on the ladder)• National & International Travel, Cross-cultural

Exposure• Increased Contacts, Marketability • Understanding of Drugs, Diseases & Management• I Love Research, Documentation, Paper Work

Overview

Clinical Research EnvironmentThe ProcessThe MarketThe PlayersThe ExperienceThe RegulationsThe EnvironmentHuman Resources

Career PathwaysCareer Models / PipelinesCareer Development Plans

Professional Skill-setsEducation & Training

Compensation, Growth & Career ProspectsCourses, Books & Periodicals

Clinical Trial (Research)

A systematic study of pharmaceutical products on human subjects – (whether patients or non-patient volunteers) – in order to discover or verify the clinical, pharmacological (includingpharmacodynamics / pharmacokinetics), and / or adverse effects, with the object of determining their safety and / or efficacy.

Types of Clinical Research

Investigator Initiated(your idea; know-how; study design)1. Federal Agency (NIH, ….)2. Contract research (Big/Small Pharma/Med Device Co, …) 3. Collaborative research (another institution)

Sponsor Initiated(their ideas; drug/device/biologic; protocol)1. Clinical trials (Phase I, II, III, IV)2. Contracted professional services3. Consulting services - tests & evaluations

Clinical Trial Process

Negotiate Budget, Identify Study Team Obtain GCP Documents, CVs, Normal ValuesInvestigator Meeting

Develop Clinical Trial

Plans

Write Protocol

Order CTMs

DevelopCRF

Prepare IB

Prepare Regulatory

Dossier

Make Regulatory Submission

Protocol Review & Approval

Screen Potential Investigators

Pre-Initiation Visits

Select Investigators

Approval

Approval

EC Submission

Initiation

Clinical Trial Process

Initiation Visit

Review…….. Protocol & IBCRFTMFTests, ProcedureIP Storage etc.SAE ReportingConsentRandomizationGCP Trg.CTM Supplies

Monitoring Visit

Protocol AdherenceSDVAE / SAE IP AccountabilityCompleteness….. Filing Essential DocsQA AuditsThird Party Audits

IInd Scrub (In-house)

Study Status Reporting

Close-outVisit

Final PaymentArchivalDrug Retrieval / AccountabilityCloseout Report

Database Lock Analysis Final Report

CRFs – DM DCFs – DM

GPPIND

Data Entry

Clinical Research Partnerships

Sponsors•Regulatory Approval•Publications•Enhanced Healthcare•Sales & Profits

CROs/SMOs/Monitors•Fee for Service•Expand research capability•Work satisfaction

Investigators•Fee for Service•Expand research capability•Academic interest/recognition•Publications•Training & special services•Patient care alternatives

Patients•Improved care•Decreased expenses•New therapies•Contribute to science

BENEFITS

The Market

5 17 21

71

7

318

100

50

100

150

200

250

300

350

1998 1999 2000 2001 2002 2005 2010

USD M

McKinsey has estimated the 2010 market size would be much higher than estimated above $1.5 – 2.0 billion by 2010

India - Advantage

Regulatory

Language

Patient Pool

Cost

Speed Fast Recruitment

30-50% less – US / EU

Vast pool of treatment naïve patients

English speaking Investigators

Regulatory facilitation of parallel phase studies

The Players

Neeman Medical, Odyssey Research, Accunova, Quintiles SMO

SIRO, Synchron, ClinInvent, Clingene, ClinWorld, ClinRx, Clintec, PharmaIntel, ACT/Suven, Reliance, Apothecaries, Clinquest

Clinical CRO (Local)

Chembiotec, DnO, Rallis, Avra, Indian Institute of Toxicology, Intox, Syngene/Biocon, Aurigene/Dr Reddy’s, Medreich, Rubicon, Natco, Bilcare

Discovery /Chemistry /Toxicology CRO

Biocon, Shanta Biotec, Bharat Serums, Panacea, Wipro, Haffkine Bio-Pharmaceuticals, Krebs Biochemicals, Bio-Rad Labs, Indian Immunological

Biotech Companies

ACE, Catalyst, ICR, Kundnani College, SIES College of Management, Kriger, Bioinformatics Institute

CR Training Institutes

Specialty Ranbaxy, Clinigene, Metropolis, Max Healthcare, Dr Lal’s PathlabCentral Laboratory

Quintiles, Synchron, Cognizant, SIRO, Accenture, DnO, ClinInvent, TCS, IBM, HCL, Infosys, Persistent Technologies, Sristek

Data Management CRO

Synchron, Lambda, Lotus Lab, Vimta Lab, Jubilant, LG Lifescience, Phoenix, Oxygen, TDM, CliniSearch, Ace Biomed, Bioassay, Reliance, PERD Centre

BABE CRO

Quintiles, Chiltern, PPD, Covance, Pharmanet, Parexel, ICON, Kendle, Pharm Olam, IGate, PRA International

Clinical CRO (Global)

Pfizer, Eli Lilly, Novartis, Dr Reddy’s, Ranbaxy, Sanofi Aventis, Astra Zeneca, Dabur, Torrent, Zydus, Altana, Sun, Merck, GSK, Wyeth, Credence, Lupin, Galderma

Pharmaceutical

Clinical Trial Experience

Infection

OncologyPsychiatry

Cardiology

Endocrinology

Gastroenterology

Orthopaedic

Ophthalmology

Paediatrics

Respiratory

Dermatology Haematology

Regulations & Guidelines

• Drugs & Cosmetics ActSchedule Y

Indian GCP GuidelinesClinical Trial PermissionImport LicenseExport License

BA BE GuidelinesMedical Devices GuidelinesICMR Guidelines for Medical Ethics

• ICH GCP Guidelines• USFDA• EU Directives

The Environment

Friendly Environment

Progressive Professional Development

Flat Structure / Team Approach

Flexibility – Flexi Timing– Flexi-work, Part Time, Full Time– Office Based, Home Based

Personality Development (Attitude, Knowledge, Skill)

Customer Orientation – Quality, Satisfaction, Repeat Business

Volatility, Attrition

People Involved in Trials in USA

78000

44000

50000

35000

0 10000 20000 30000 40000 50000 60000 70000 80000 90000

Sponsor Staff

CRO Staff

Investigator

Other Site Staff

Source : CenterWatch 2001

Demand Supply Gap : 2010 - India

200

1000

300

400

1000

6000

2000

4000

0 1000 2000 3000 4000 5000 6000 7000

Sponsor Staff

CRO Staff

Investigator

Other Site Staff

DemandSupply

Rough Estimated Figure

Career Pathways

• Pharmaceutical Companies• Clinical CROs (Contract Research Organizations)• BA/BE Centers• SMOs (Site Management Organizations)• AROs (Academic Research Organizations)• Data Management CROs• IT Companies in Healthcare / Clinical Domain• EDC Service Providers• Central Laboratories• Packaging & Labeling & Contract Manufacturers• Investigator & Site Staff • Training Centers

Functions in Career Pathways

Project Management Phase I Unit

Central Laboratory & Vendor ServicesSite Management

Quality Assurance Contract Staffing

Pharmacovigilance Data Management

Pharmacy / Distribution Bio-statistics & Medical Writing

Career in CROs / Pharma / Biotech Companies

Clinical Trial Assistant (CTA)Clinical Research Associate (CRA)Senior CRAClinical Team LeaderProject ManagerSenior Project ManagerManager Medical & RegulatoryManager – Safety / PatentsManager Quality AssuranceMedical DirectorAssociate Director – ClinicalAssociate Director – ProjectsDirector – Business DevelopmentDirector / Head (Clinical Operations)General Manger / CEO / President

Phase I / II / III / IV Trial

Project ManagementDrug Development PlanningMonitoring Source Data VerificationSafety ReportingRegulatory ApprovalQA AuditsBusiness Development

Career in SMO / AROClinical Research Coordinators (CRC) / Study CoordinatorsPrincipal Investigators / Co-InvestigatorsMedical MonitorsProject Manager / Senior Project ManagerManager Medical & RegulatoryManager Quality AssuranceManager – Business DevelopmentMedical DirectorAssociate Director – ClinicalAssociate Director – ProjectsDirector / Head (Clinical Operations)General Manger / CEO / President

Investigator Support

RecruitmentPatient Follow upCRF FillingDrug AccountabilityPatient ConsentPatient SafetyData Quality

Career in Clinical Data ManagementData Entry OperatorData Validation ExecutiveQA ExecutiveData ManagerQA ManagerStatistical ProgrammerStatisticianData ReviewerData Base DesignerMedical WriterHead – Data Management

Data Base DesignData Entry Data ValidationData ReviewStatistical ProgrammingMedical Writing

Career in BABE CentersClinical Research Associate (CRA)Project ManagerManager Medical & RegulatoryManager – Safety / PatentsManager Quality AssurancePhysiciansLaboratory Technicians / Head(s)StatisticiansPrincipal InvestigatorMedical WriterMedical DirectorAttendants / VolunteerBusiness Development ManagerDirector / Head / CEO

Bioanalytical Study

Volunteer SelectionBioanalysisQA AuditsBiostatisticsPharmacyReport Writing

Bioequivalence Study

Career in IT Companies & EDC Service Providers on Clinical Domain Domain ConsultantOracle ProgrammerData ReviewerData Base Designer SAS / Statistical ProgrammerProject Manager Validation Executive / ManagerQA Executive / ManagerStatisticianEDC TrainersBusiness DevelopmentHead – Healthcare / Life sciences

Software Solution DesignProgrammingTrainingImplementation Validation

Career in Training Institutes

Lecturer / Trainer Associate Professor /Professor

– Clinical Trial Management– Data Management– Bio-Statistics– GCP, Regulation– Project Management– Project Finance– Logistics

Training CoordinatorsTraining Director

Training Fresh TalentsTrain The TrainerTrain The Professionals

Career Pipelines

Principal InvestigatorConsultant

Study Coordinator, Co-Investigator, Principal Investigator

Study Coordinator

Physicians / Therapeutic Specialist in Diverse Therapeutic AreaPipeline 5

Head (HR), Director – Business Development, Head (Logistics), Head (Finance), Head (Training & Development)

Manager Business Development, Manager (Clinical Trial Supplies, Manager (Accounts), Manager (HR), Manager (Training)

Accounts/HR Executive, Business Development Executive

Graduate / Post-Graduates, MBA including HR, FinancePipeline 4

Head Data Management,Biostatistician

Data Manager, Statistician, SAS Programmer, QC Manager

Data Base Designer, Statistical programmer, Data Validation / QC Executive

Graduates / PG / PhD in Mathematics & Statistics, SAS Programmer, etc.Pipeline 3

Head (Operations), Associate Director (Clinical Operations), Head (Projects), General Manager, CEO

Clinical Team Leader, Project Manager, Manager (Clinical Operations), QA Manager, Data Manager, Clinical Study Manager, Clinical Development Manager, Regulatory Manager, Project Manager

CRA, Senior CRA, Data Entry Operator, Data Validation Executive, QA Executive, Pharmacy Executive

BPharm / MPharm / Graduates / Post-Graduates (Science, Nursing, Biotech, Alternate Medicines), MBA, PhD

Pipeline 2

Medical Director, Head (Clinical Operations), Consultants

Medical Advisor, Regulatory Affairs Manager, Medical Monitor, Medical Writer, Safety Officer

CRA, CRC, Study Coordinator

MBBS / MD (Pharmacology) Pipeline 1

5-15 Years Experience

2-5 Years Experience

Fresh – 2 Years Experience

Selection Process

Written Test- English- Medical Terminologies - Essay writing, on career path

Presentation- To assess communication

(speaking, language, confidence)Personal Interview

- Clarity of thoughts, career goal- Priorities, interests- Attitude- Computer skills- Knowledge of clinical research / GCP / Regulations - Understanding of the job profile- Communication skill

Knowledge

Basic knowledge Drug Development ProcessClinical Trial Design & Statistics Adverse Events & Toxicology Regulatory & Ethics (GCP, GMP, GLP) Pharmacy, Pharmacokinetics, PharmacologyDisease, Diagnosis, DrugsInformation Technology, Computing Skills

Skill

Interpersonal Skills – People ManagementCommunication Skills –•Written, Verbal, Presentation Time ManagementLeadership & TeamworkDiplomacy & Conflict ManagementBusiness AcumenDecision Making & Crisis ManagementPlanning SkillsFinancial Management

Home Based Regional Based

Sponsor officeBased

CRO OfficeBased

Office Based

CRO Staffing Models

Cost Effectiveness

10%360036000CTA

24%1750073000Regulatory Affairs

24%1750074000Project Manager

12%775065000Regional CRA

11%775068000Senior CRA

11%555552000CRA

%India, 2005 Annual Gross Salary

US$

2001 Annual Gross Salary*

US$

Position

* Source: CenterWatch

Clinical Profession Advantage

Executive/ Mgr (QA)450000-600000Quality Assurance (3-5)

Area Manager (2-3)150000-200000CTA / DEO (0.5-1)

ZM/SM (8-10)600000-800000Regulatory Affairs(3-5)

RM/ZM/SM (8-10)450000-600000Project Manager / Data Manager (3-5)

RM/ZM/SM (6-8)300000-450000Regional CRA(2-3)

Manager/ RM/ ZM (6-8)

300000-450000Senior CRA (2-3)

Executive / RM / ZM (6-8)

200000-300000CRA / Data Coordinator (1-2)

Position in Comparable

Industry

Annual Salary Rupees

Position

* Source: CenterWatch

Training Institutions / Courses

Diploma, Short Term CourseKundnani College ofPharmacy Mumbai

1 module on clinical research as Part of PGD-Pharmaceutical Mgt

www.siescoms.eduSIES College of Management, Nerul

www.krctraining.net

www.clinicpune.org

www.pexa.org

www.icriindia.com

www.aceindia.org

2080 USDKriger Research

Certificate course in ClinicalResearch and Data Management– 6 months

University of Pune

Certificate courses, 6 months,Fees ~ Rs 25000

PEXA - Mumbai

Post Graduate Diploma in Clinical research,Fee~Rs1,15,000

MSc. (Clinical Research)– 2 years, Approx. 3 Lakh Rupees

Institute of ClinicalResearch, Mumbai,Delhi, Bangalore

Post Graduate Diploma in Clinical research,7-8months, Fee~Rs40,000

Academy of ClinicalExcellence - Mumbai

Certification

www.mcmaster.ca

www.socra.org

www.acrpnet.org/education/examrev/cracourse.html

5 years experience required. Fees 60 USD

McMasterUniversity

2 years experience required. Fees 195 USD

SoCRA

2 years experience required. Fees 100 USD

ACRP

Online Courses

www.krctraining.net

www.bii.in

www.clinfosource.com

www.nihtraining.com

$ 1580 Kriger Research Canada

6 monthsRs 5000

BioInformatics Institute of India

Certificate$100 - 500

ClinfoSource

certificateNIH Training

Academy for Clinical Excellence (ACE)

• Foundations of Clinical Research & GCP

• Ethics Committee – Composition and Function

• Advanced Module on Protocol Design

• GCP for Investigators

• Diploma in Clinical Research

Suggested Books / Materials for Reading

• GCP-SOP for Clinical Researchers Joseph Kolman

• Handbook of Clinical Research Julia Llyod, Ann Raven

• Monitoring Clinical Research Karen E. Woodlin & John C S

• Drugs & Cosmetics Act-1940 Vijay Malik

• Methodology of Clinical Drug Trials Edelstein,Weinstraub

• Clinical Trials Stuart Pocock

• Fundamentals of Clinical Research Lawrence Friedman

• Which Document, Why? David Hutchinson

Suggested Magazines / Journals

• ACRP Monitor $12 (Annual Membership)

• Contract Pharma Free, www.contractpharma.com

• Applied Clinical Trial Free, www.actmagazine.com

• GCPj www.gcpj.com

• Pharmabiz Asia www.pharmabiz.com

• Express Pharma Pulse www.expresspharmapulse.com

• Pharmabioworld www.pharmabioworld.com

• Biospectrum India www.biospectrumindia.com

Worth Reading – If Interested

1. Career in Clinical Research - India, ACRP Monitor, Volume 19, October 2005

2. Communiqué : Clinical research in India, Contract Services Europe, www.csemagazine.com, March 2006

3. Subject Recruitment : An Indian Perspective, Applied Clinical Trials, www.actmagazine.com, Feb 2006

4. Clinical Trials in India : The Reality, ACRP Monitor, Feb 20065. Bioavailability and Bioequivalence Trials, A Promising Business

Opportunity in India, ACRP Monitor, will be published in Jun 2006 issue6. A Fair Trial, Pharmaceutical Manufacturing and Packing Sourcer, Spring

2006, www.samedanltd.com (to be published)7. Look East for the future development of new drugs & speedy clinical

trials; Pharmaceutical Journal (Vol 275), 26 November 2005, www.pjonline.com

8. Contract staffing - A pill for many an ill, 16 March 2006, Chronicle Special, Pharmabiz Asia, 2006

Worth Reading – If Interested

9. 2010 - Indian Clinical Research Odyssey - Pharmabiz, February, 26, 200410. EDC - A new mantra for clinical trials - Pharma Pulse, April, 01, 200411. Laboratories & Clinical Trials in India, ACRP Monitor, Summer 200412. Clinical Trial in India : Monitoring Issues, ACRP Monitor, Fall 2004 13. Challenge of patient recruitment and retention: Critical role of clinical

research coordinator, Pharmabiz, July 08, 200414. Global Clinical Trials - from Metro-centric to Multi-centric: A Herculean

Task, Express Pharma Pulse, July 29, 200415. “Y Trial in India”, GCPj, July 2005, www.gcpj.com16. “India – The Future Clinical-Trials Destination, PharmaVOICE, July 200517. “Indian CRO Industry – The Talent Pool”, Global Outsourcing Review18. “Clinical Data Management Outsourcing – India, A Review of Cost and

Competition”, EyeforPharma & Express Pharma Pulse, June 200519. “Data Capture Shifts Paradigm, EDC Vendors Eyeing India”, Chronicle

Pharmabiz Asia, July 2005

All the best.