Catalyst Clinical Services Private Limited

Clinical Researches are specialized activities that are a vital and integral part of development of new medicines, drugs, biologics and devices. Our advanced certification programs are designed to impart the technical knowhow and competencies to enable our candidates to carry out specific responsibilities and activities pertaining to Clinical Researches. Our successful candidates have gone ahead to assume positions of Clinical Research Associate, Project Manager and Scientific Writer in various reputed firms. The unique hands-on experience based training have helps them to fast career growth in the industry.

 

The duration of the course is 6 months. Our courses provide specialization in the following fields:

• Advance Certificate in Clinical Trial Project Management,
• Advance Certificate in Clinical Trial Monitoring,
• Advance Certificate in Scientific Writing and Creation of Essential Documents

Eligibility:

All working professional who have competed the following degree courses and diplomas are eligible for the OCTT course. Final year students, completing their courses this year can also apply for enrolment in the program.

• B.Pharm, M.Pharm, Ph.D
• M.B.B.S, M.D, M.S, D.N.B, D.M
• B.D.S, M.D.S, B.P.T, B.Tech
• B.A.M.S, B.H.M.S, B.U.M.S
• B.Sc, M.Sc, Ph.D
  

All the courses have been designed comprehensively designed. The detailed course materials subjects and program elements for the 3 advanced courses are as follows:

 

Advance Certificate in Clinical Trial Project Management

Program Elements:

• Introduction to Clinical Research, Guidelines and Standards Governing Clinical Research
• Project Milestones Planning and Forecasting
• Cost Estimate and Financial Planning
• Logistics Planning, Vendor Selection and Management
• Clinical Study Process (multi-centric) and Creation of Trial Master File(s)
• Management of Regulatory Document Submission
• Co-ordination of Individual Site Set-up Activities
• Import/ Export Authorization
• Organization of Investigator Training Meeting
• Study Initiation, Conduct and Milestones Tracking
• Audit(s) and Quality Assurance
• Study Closeout (trial completion, suspension, termination etc.)

Advance Certificate in Clinical Trial Monitoring,

Program Elements:

• Introduction to Clinical Research, Guidelines and Standards Governing Clinical Research
• Site Initiation, Review of Essential Trial Documents, Delegation of Duties and Responsibilities at Individual Site
• Inventory Planning and Tracking
• Clinical Trial Monitoring
• Source Document Verification (SDV)
• CRF Review, Collection and Co-ordination of Data Management Activities
• Serious Adverse Event (SAE) Review and Regulatory Compliance
• Investigational Product Accountability and Management
• Escalation, Management and Prevention of Violations/Deviations
• Tracking of Enrolments, Payments and Ongoing Correspondence
• Site Closure
  

Advance Certificate in Scientific Writing and Creation of Essential Documents,
Program Elements:

• Introduction to Clinical Research, Guidelines and Standards Governing Clinical Research
• Development of Standard Operating Procedures (SOPs) 
• Protocol 
• Informed Consent Document (ICD)
• Clinical Report Form (CRF)
• Data Validation Plan (DVP)
• Clinical Study Report (CSR)

Our Professional Diploma in Clinical Research arms our candidates with knowledge and skills to understand the fundamentals and essentials of Clinical Research, helping them to carry our researches that determine effectiveness, safety and side effects of new drugs and treatments. The details of the various components of the 4 course modules are:

Module-I: Introduction to Pharmaceutical Medicine

• The Drug Development Process
• New Drug Discovery
• Clinical Development of Drug
• Essential Clinical Trial Documents
• Clinical Trials Terminology

Module-II: Good Clinical Practice (GCP) Foundations

• History of GCP - milestones in the evolution of GCP
• Principles of GCP
• Applicable GCP Guidelines 
• Declaration of Helsinki 
• Clinical Study Process
• The Management of Clinical Studies (Sponsor)
• Ethics in Clinical Research
• Informed Consent
• Serious Adverse Event (SAE)
• Challenges in the Implementation of GCP Guidelines
• Biostatistics
  

Module-III: Drug Regulatory Affairs (Clinical Trials)

• Overview of Regulatory Environment in USA, Australia, Europe and India  
• Clinical Trial Application Requirements in India
• Import- Export of Clinical Trial Drugs in India
• Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule

IND/ANDA/New Drug Application

Module-IV: Roles and Responsibilities of Clinical Trial Personnel

• Roles and Responsibilities of Sponsor
• Roles and Responsibilities of Investigator
• Roles and Responsibilities of ERB/IRB/IEC
• Roles and Responsibilities of CRA /Monitor
  Roles and Responsibilities of Auditor
• Roles and Responsibilities of Clinical Research Coordinator or Site Manager
• Roles and Responsibilities of CRO’s
• Roles and Responsibilities of Regulatory Authorities
• Roles and Responsibilities of Clinical Data Manager (CDM)
• Roles and Responsibilities of Clinical Biostatistician