Clinical  

Trial  Process

Version:  1.0

©  2010  International  Drug  Discovery  a nd  Clinical  Research.  A ll  rights  reserved.  

 Objectives
To  get  an  overview  of  the  clinical  trial  process  flow.

©  2010  International  Drug  Discovery  a nd  Clinical  Research.  A ll  rights  reserved.  

Clinical  Trial  Process  Flow

©  2010  International  Drug  Discovery  a nd  Clinical  Research.  A ll  rights  reserved.  

Clinical  Trial  Process
End
No No
Yes
Ethics, Yes Design of Study Pre-study planning:
Document (Protocol, Approvals personnel, tools,
Feasibility,
Significance CRF, ICF) systems

Conduct of the study: Recruitment of the Investigators’ meetings

Site Closing
participants, informed consent, Clinical Practical planning
meeting
examinations, Documentation Training

Submission of CSR to Yes Archiving

Data Mgt Approvals Manufacturing
National Agency for of the data
& stat analysis for market.
Medicines
No
End

©  2010  International  Drug  Discovery  a nd  Clinical  Research.  A ll  rights  reserved.  

Clinical  Trial  Systems  – Key  Application  Areas
§ Protocol  Development
§ Investigator/Site  Selection  and  Trial  Preparation
§ Subject  Identification  and  Enrolment
§ Collection,  Monitoring  and  Processing  of  Data
§ Data  Analysis  and  Reporting
§ Safety  and  Adverse  Event  Reporting  -­‐‑ Pharmacovigilance
§ Submission  for  Review  by  Regulatory  Authorities

Company  Confidential.  Copyright   5

©  2010  International  Drug  ©  2009  
Discovery  aLnd  
AXAI
Clinical  Research.  A ll  rights  reserved.  
 Clinical  Trial  Systems  – Stakeholders
§ Protocol  Development    
ü Principal  Investigator
ü Trial  Sponsor
§ Investigator/Site  Selection  and  Trial  Preparation  
ü Sites
ü Trial  Sponsor
ü IRB

Company  Confidential.  Copyright   6

©  2010  International  Drug  ©  2009  
Discovery  aLnd  
AXAI
Clinical  Research.  A ll  rights  reserved.  
Clinical Trial Systems – Stakeholders
§ Subject  Identification  and  Enrolment
ü Sites
§ Collection,  Monitoring  and  Processing  of  Data
ü Trial  Sponsor
ü Sites

Company  Confidential.  Copyright   7

©  2010  International  Drug  ©  2009  
Discovery  aLnd  
AXAI
Clinical  Research.  A ll  rights  reserved.  
 Clinical  Trial  Systems  – Stakeholders  – Cont…
§ Trial  Management
ü Trial  Sponsor,  Sites
§ Data  Analysis  and  Reporting
ü Trial  Sponsor
§ Submission  for  Review  by  Regulatory  Authorities
ü Trial  Sponsor  to  agency

Company  Confidential.  Copyright   8

©  2010  International  Drug  ©  2009  
Discovery  aLnd  
AXAI
Clinical  Research.  A ll  rights  reserved.  
 Clinical  Trial  Systems  – Technology  Usage
§ Protocol  Development  –
ü Word  Processing  software  such  as  Word,  Adobe
ü Document  Management  Solutions  such  as  Documentum    for  
organizing  and  standardizing  the  process  of  protocol  
development

§ Investigator/Site  Selection  and  Trial  Preparation  

ü In  House  Tracking  systems  to  track  receipt/  approvals    of    
documents  
ü Internet  based  software  systems  

Company  Confidential.  Copyright   9

©  2010  International  Drug  ©  2009  
Discovery  aLnd  
AXAI
Clinical  Research.  A ll  rights  reserved.  
Clinical  Trial  Systems  – Technology  Usage  
• Second  Generation  EDC  tools
– Integrated  functionalities  with  much  more  clinical  trial  
process  functionalities
– Extensive  usage  of  internet
– Hybrid  systems  with  2  modes  of  operations,  online  and  
offline
– Enhanced  IVRS

Company  Confidential.  Copyright   10

©  2010  International  Drug  ©  2009  
Discovery  aLnd  
AXAI
Clinical  Research.  A ll  rights  reserved.  
Study  Documents
Three  impartment  documents  to  start  a  trial:  

– Protocol
– Informed  Consent  Form
– Case  Report  Form

©  2010  International  Drug  Discovery  a nd  Clinical  Research.  A ll  rights  reserved.  

 Thank  
You

©  2010  International  Drug  Discovery  a nd  Clinical  Research.  A ll  rights  reserved.