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| What is Clinical Research ? |
| Clinical Research is a systematic study for new drugs in human subjects to generate data for discovering or verifying the Clinical, Pharmacological (including pharmacodynamic and pharmacokinetic) or adverse effects with the objective of determining safety and efficacy of the new drug. |
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Clinical Research Industry - An Indian Perspective
India has become a signatory to TRIPS. Consequently, a new patent law has come into effect from January 2005. The new keyword for the pharmaceutical industry is innovation and to introduce new drugs, clinical trials are mandatory. They are to be conducted as per ICH GCP norms. The clinical trials that have been conducted in India till date have gone well. For majority of the studies, patient enrollment is a key advantage. This helps compress the development timeline and data quality is excellent.
Numerous audits in India are a testimony to level of quality. And data from clinical study in India have been successfully filled with international regulatory agencies. The potential realized at present is a fraction of the possible in India. Consistent with WTO guidelines effective from 2005, India will also offer 10-year tax concessions on revenue to companies making Research & Development (R&D) investments here. These incentives are expected to substantially increase R&D activities of both multinational and domestic biopharmaceutical companies. Analysts are projecting that total Clinical Research spending in India will increase by more than 30% annually through 2010.
India is increasingly being recognized as a hub for global clinical trials as it has several prized attributes:
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Large and diverse patients' pool for conducting clinical trials |
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Availability of Medical, Pharmacy and Science graduates |
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Excellent infrastructure facilities |
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Comparative cost advantage |
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Changes in the Patent Laws |
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Clinical Research - The Future
The Clinical Research industry in India has grown from Rs 20 crores to Rs 100 crores in the last three years. As per a recent McKinsey report, it is expected to touch Rs 5,000 crores by 2010 and will employ 50,000 people in the next five years.There will be a huge demand for qualified and trained Clinical Research Professionals.
Many pharmaceutical organizations and Clinical Research organizations have already come forward to unlock the vast potential that India has, and are conducting Clinical Trials in India. |
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| OUR OBJECTIVES |
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Be recognized as a centre of excellence and become a pioneering institution in promoting ethical Clinical Research in the country.
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Give a boost to the development of Clinical Research in the country. |
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Keep Indian Clinical Research Industry abreast of changing times. |
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Represent the interests of Clinical Research Professionals in the country and ensure that India does not lag behind in maintaining the internationally prescribed standards of Clinical Ethics. |
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| Clinical Research - Career Prospects |
India is looked upon as a reliable destination for outsourcing, conducting clinical trials and associated areas of clinical research like medical writing, regulatory writing, data management, statistics, pharmacovigilance etc.
In the last 5 years there has been a steep rise in the global demand for professionals with training in clinical research operations. After our training you will see yourself with detailed knowledge and understanding of current status with practical applications in the various domains of clinical research industry and ready to take up key roles in development and commercialization of drugs, biologics, and medical devices
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Clinical Research Coordinator |
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Clinical Research Associate |
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Clinical Trial Team Leader |
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Clinical Project Manager |
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Business Development Executive |
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Clinical Data Associate |
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Clinical Data Validator |
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Clinical Data Reviewer |
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Clinical Data Manager |
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Medical Writer |
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ScientificWriter(Medical Communications) |
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Regulatory Affairs Officer |
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Clinical SAS Programmer |
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Clinical Data Analyst |
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Statistical Analyst |
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Drug Safety Associate |
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Case Processing Associate |
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Drug Safety Monitor |
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Medical Reviewer |
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Safety Processing Expert |
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Clinical/Bioanalytical Study Auditors |
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Training
OUR’s training modules cover the whole spectra of issues critical to the successful operation within the clinical trial industry. Each set of training modules are oriented to specific department or group of employees within a company and can be customized according to requirements of specific SOP’s. When a company chooses an outsourced training solution, they gain immediate access to OUR’s skilled training specialists who can provide training sessions at their premises or to become their virtual training department.
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| MODULE–I (PHARMACEUTICAL MEDICINE) |
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Introduction to the Pharmaceutical Medicine |
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Introduction to the Pharmacology |
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Development Process |
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Preclinical Testing – Pharmacology Testing |
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- Toxicology Testing |
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- Animal Pharmacokinetic Testing |
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Clinical development |
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- Introduction, Objectives and Design of Phases of trial I, II, III, IV |
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- Types of Clinical Studies |
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Essentials Clinical Trial Documents |
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Biostatistics |
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- Introduction |
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- Applications |
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| MODULE–II (DRUG REGULATORY AFFAIRS) |
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Overview of Regulatory environment in USA, Europe and India |
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Clinical Trail Application Requirements In India |
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Import- Export of clinical Trial Drug in India |
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IND/AND/New Drug Application |
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| MODULE–III GOOD CLINICAL PRACTICE |
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History of GCP |
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Principles of GCP |
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Applications of GCP |
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Declaration of Helsinki |
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Challenges in the Implementations of GCP Guidelines |
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Ethics in Clinical Research |
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Clinical Trail Terminology |
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| MODULE-IV - ROLES AND RESPONSIBILITIES OF CLINICAL TRIAL PERSONNEL |
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Sponsor |
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Investigator |
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ERB/IRB’s |
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CRA |
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Auditors |
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Site coordinator |
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CRO |
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Regulatory Authorities |
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Data Managers |
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Bio statistician |
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| MODULE-V CLINICAL DATA MANAGEMENT(CDM) |
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Importance, overview, Data flow, over all process, methodology of DM |
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Database design, considerations, tools (EDC, RDC), shortcomings |
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Medical/clinical Coding (MedDRA, WHODD, COSTART) |
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Third party reconciliations |
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SAE reconciliations |
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Introduction to CDISC, SCDM |
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Overview on Oracle Clinical |
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| MODULE–VI PHARMACO-VIGILANCE |
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Introduction |
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Objectives |
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Diagnosis of AE |
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Causality assessment |
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| MODULE-VII SAS WITH CLINICAL TRAILS |
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SAS/BASE |
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SAS/MACROS |
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SAS/GRAPH |
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SAS/STAT |
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SAS/SQL |
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PROJECT IN CLINICAL TRIALS |
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| ELIGIBILITY FOR CLINICAL RESEARCH AND SAS |
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Graduates and Postgraduates with specialization in all life sciences streams (BSc , Btech, ME/M.Tech Etc..) |
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Graduates and Postgraduates with specialization in any of the areas of Pharmacy (B.Pharm, M.Pharm, etc.) |
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MSc (Maths, Stats), Software Professionals, etc. |
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