Chandrakant Roy has over 10 years of experience in clinical research as a research associate, clinical trial assistant, and clinical research coordinator. He has worked on Phase III and Phase IV clinical trials across various therapeutic areas. Mr. Roy holds an M.Sc. in Biomedical Sciences and a post-graduate diploma in clinical research. He is proficient in ICH GCP guidelines and has experience in clinical data management, monitoring, and pharmacovigilance activities. Currently, he works as a research associate at Quest Care Pvt Ltd conducting BA/BE studies.

1. CHANDRAKANT ROY
Email: chandrakant_biomed@yahoo.co.in , chandrakant.cr@gmail.com
Mobile No. : +91 7069199891 (Kandla Gujarat), 9972945920(Bangalore),
Gujarat, India
CORE COMPETENCY
PROFESSIONAL SUMMARY
 Works at QUEST CARE PVT LTD CRO Kandla /Gandhidham (Gujarat) as Research Associate-
Clinical Trial Department BA/BE Study.
 Worked at (NOVA HRO) Novartis / Alcon Laboratories India Pvt Ltd Bangalore as Clinical Trial
Assistant.
 Worked at JSS Medical Research India Pvt. Ltd. (Formerly Max Neeman Internayional) Canadian
CRO Bangalore as Clinical Trial Assistant.
 Worked at CHANRE RHEUMATOLOGY & IMMUNOLOGY CENTER & RESEARCH
BANGALORE as Clinical Research Associate.
 Worked at NARAYANA NETHRALAYA SUPER SPECIALITY EYE HOSPITAL BANGALORE
as Clinical Research coordinator.
 Worked at TECH-OBSERVER GLOBAL CRO NEW DELHI as Clinical Research coordinator.
 Worked at INTERFACE PHARMACEUTICALS PVT.LTD. NEW DELHI as Sales and Marketing
Executive.
 Worked at CLINIMINDS CLINICAL RESEARCH BANGALORE as Business Development Executive.
 Completed M.Sc.in Biomedical Sciences (2006-08) from Bundelkhand University, Jhansi.
 Completed PGDACR (1 year full time, 2009-10) in Clinical Research, from ICRI, Bangalore.
 Certificate of Completion ICH GCP For Clinical Trail Sites Provided by Quintiles Global Learning.
 Certificate of Completion ICH GCP For Clinical Trail Sites Provided by Eli Lilly .
 EPX Provided by Electronic Signature Certificate.
 BA/BE, PK/PD Sample infusion, shipments Ambient & Frozen, Conducted PK/PD studies in human
subjects.
 Quintiles- Infosario-Global Support Investigator Laboratory& Training Certificate Provided.
 Training attended Basic GCP Association of Clinical Research Originations, (ACRO) India. On 17 Sep
2016 at Zydus Hospitals, Ahmedabad.
EXPERIENCE SUMMARY
 Introduction to Clinical Research & Phases in Clinical Research
Clinical Research Medicinal Chemistry
Molecular Biology & Biochemistry Biomedical Instrumentation
Immunology & Biostatistics Pharmacology & Toxicology

2.  ICH GCP, Indian GCP, ICMR Guidelines.
 Drug and Cosmetic act-Schedule Y, USFDA, European Union rules and regulations.
 Principles of Pharmacology & Drug Discovery & Development.
 Protocol Designing, Protocol development, Preparations & Planning for Clinical Trials.
 Essential Documentation filling & maintenance in Clinical Research & Regulatory Submissions.
 Clinical Trials Project Planning & Management.
 Monitoring essentials and checklists.
 Informed Consent process, enrollment, Case reports, Study reports, Source documents.
 Study Start up Process.
 Feasibility studies, Pre site visit, routine monitoring, adverse event reporting and Study close out.
 Drug & biological sample accountability, Coordination in investigational site.
 General Overview of Pharmacovigilance:
 Medical Dictionary for Drug Regulatory Activities MedDRA
 Regulatory Aspects in Pharmacovigilance
 Diagnosis And Management of Adverse Drug Reactions
 Medical Evaluation of Adverse Events
 Periodic Safety Update Reports (PSUR,s) For Marketed Drugs (ICH E2C)
 Pharmacovigilance Database And Signal Detection Tools
 Risk Assessment, Evaluation and Management.
 Reconciliation of Adverse Events/Serious Adverse Events due to Drug Products with ARGUS safety
database (Pharmacovigilance).
 Clinical Data Management: Data&Databases,Data Management and Data Management Plan, Data
Entry, Transcribing Data, Identifying and Managing Discrepancies, Cleaning Data, Data Tracking the
CRFs,Study Setup, Design Considerations, Electronic Data Capture.
 eCRF designing and programming in Oracle Clinical for RDC of clinical trials
 BA/BE Studies in Drug Development.
 Biostatistics in Clinical Trials.
 Standard Operating Procedures (SOPs), Good Laboratoty Practices (GLP), Good Manufacturing Practice
(c GMP), Packaging and Labeling etc.
 IEC / IRB submission or notification procedure for approval of Study Procedure, Documents, Safety
Reports / updates etc.
 Medical Writing.
CLINICAL TRIAL EXPERIENCE
Indication of Trial Clinical Phases
of Trial
Role in the
Trial
Year of
Conduct
Variable Study: Vildagliptin + Metformin versus
Glimepiride + Metformin on
glucose variability in T2DM patients
IV CRC 2013
Wet Age Related Macular Degenaration
(IBPL_RN_01) Ranibizumab/ Lucentis®.
III CRC 2014
Nonvascular Age Related Macular III B CRC 2014

3. DegenarationRFB002/Ranibizumab/Lucentis®
(TREND STUDY)
Chordial Neovascularization Secondary to
pathologic myopia/Ranibizumab Vs Verteporfin
PDT(BRILLIANCE STUDY)
III CRC 2014
Diabetic macularEdema/Lucentis/Observational
Study
IV CRC 2014
Acute Non-Arteritic Anterior Ischemic Optic
Neuropathy/QPI-1007(NAION STUDY).
III CRC 2014
Chronic Open Angle Glaucoma (COAG)or
Ocular Hypertention(OH)in both
Eye.Brinzolamide 1% Ophthalmic Suspension
Watson Pharma Pvt Ltd.
III CRC 2014
Chronic Open Angle Glaucoma (COAG)or Ocular
Hypertention(OH) Brinzolamide 1% Ophthalmic
Suspension of Cipla Ltd.
III CRC 2014
Glaucoma Screening Study Global Study. Methodology
Validation
CRC 2014
I4V-M7C-JADX& I4V-MC-JADZ study(Eli
Lilly Baricitinib Phase III Rheumatoid Arthritis).
III CRC 2015
DRL RI_01_003 Study (DRL_Rituximab) Phase
III Rheumatoid Arthritis ). Dr. Reddy Lab.
III CRC 2015
Kenacort® Injection 10 mg/40 mg
(triamcinolone acetonide) Protocol Number:
AHPL-IN-15-09 Observational, Prospective, Post
Marketing
IV CTA 2015
Study of Tresiba ® (insulin degludec)
to evaluate long term safety and efficacy in
patients with diabetes mellitus in routine
clinical practice in India
IV
(Post marketing
surveillance.)
CTA 2015
(PMS) study of Ryzodeg (insulin degludec
/insulin aspart) to evaluate long term safety and
efficacy in patients with diabetes mellitus in
routine clinical practice in India.
IV
(Post marketing
surveillance)
CTA 2015
CERTIFICATION/TRAINING ATTENDED
 Training attended Basic GCP Association of Clinical Research Originations, (ACRO) India. On 17 Sep
2016 at Zydus Hospitals, Ahmedabad.
 Regulatory Guidelines,ICH-GCP, IVRS/IWRS Tech-Observer Pvt Ltd India(in2013)
 Certification in ORACLE RDC 4.5.3/4.6 from Quintiles (in 2014)
 RDC Onsite for CRC:e-CRFs,Oracle RDC Novartis(in2014)
 EDC-Application for IBPL-RN-01-Study Octalsoft(in2014)
 Certificate of Completion ICH GCP for Clinical Trail Sites Provided by Quintiles Global
Learning (2015).

4.  Module 1: Introduction to the Clinical Drug Development Process: ICH-GCP.
 Module 2: Clinical Investigator obligations&Qualifications, Resources, IRBs/IECs.
 Module 3: Subject Informed Consent&Protocol Compliance.
 Module 4: Investigational Product, Randomization, and Unblinding & Source Documents and Case
Report Form Completion.
 Module 5: Safety Reporting, Financial Disclosure & Study Closeout, Trial Termination, and Record
Retention.
 Module 6: Non-Compliance, Scientific Misconduct and Fraud & Monitoring and Preparing for Audits
and Inspections.
 Module 7: The European Clinical Trial Directives.
SEMINAR PRESENTED (During College study)
 Ion-Exchange Chromatography (2006).
 Carbohydrates (Diasaccharide) 2007)
 Immune response (2007).
Educational Details
 Completed PGDACR (1 year full time) in Clinical Research, from ICRI, Bangalore.
 Completed M.Sc in Biomedical Science from Institute of Biomedical Science, Bundelkhand
University, Jhansi
 Completed B.Sc in Zoology(H), Botany, Chemistry from Vinoba Bhave University, Jharkhand
PROJECT WORK
Worked at CloneGen Biotechnology Pvt. Ltd., Noida as Project trainee from Feb 2008 to July2008 .
Project Detail:
Isolation and Biochemical analysis of Alpha amylase isolated from Bacillus amyloliquefaciens and
optimization of culture conditions of the Bacillus in stress conditions.
IT SKILLS
Good on MS -office: Word, Excel & PPT. Oracle: (SQL, PL/SQL, SAS etc) from NICT Bangalore.
PERSONAL/SOFT SKILLS
 Presentation and Public Speaking
 Event planning and coordination
 Positive Attitude, Determined, High Energies.
 Hard Working, and Sincere.
PERSONAL PROFILE
Name : CHANDRAKANT ROY

5. Date of birth : 1st March 1978
Gender : Male
Nationality : Indian
Languages Known : Hindi, English
Residence : Bangalore, Karnataka
REFERENCE
 Dr. Rambir Singh (HOD)
Department of Biomedical Sciences Bundelkhand University, Jhansi
 Dr. Pravina koteshwar(principal)
MBBS, MD (pharmacology) ICRI, Bangalore
DECLARATION
I hereby declare that the above information furnished is true to the best of my knowledge and belief.

6. Date of birth : 1st March 1978
Gender : Male
Nationality : Indian
Languages Known : Hindi, English
Residence : Bangalore, Karnataka
REFERENCE
 Dr. Rambir Singh (HOD)
Department of Biomedical Sciences Bundelkhand University, Jhansi
 Dr. Pravina koteshwar(principal)
MBBS, MD (pharmacology) ICRI, Bangalore
DECLARATION
I hereby declare that the above information furnished is true to the best of my knowledge and belief.