Research organization

• Global Activity
• Therapeutics Areas
• Start-up times - Contracting process
• Services
• Recruitment strategy
• Communications - experience with EDC (e-CRF)
• Oversight for safety & protocol adherence
• Pharmacy

Global Activity

Therapeutics Areas

Start-up times - Contracting process

CIC Services

Clinical development - regulatory services

Project development
Protocol, CRF design
Investigator identification
Safety reporting to regulatory authorities

Feasibility Studies

Investigator site selection
Availability of investigators and patients
Probable recruitment rates

Data Management

CRF design/production
Database design/setup
Data entry
Data validation/cleanup

Clinical Study Management

Project implementation

Initiation visits
Study management documentation
Protocol design and distribution
CRF preparation, printing, and distribution

Project management

Enrolment tracking
In-house CRF review
AE review and reporting
GCP/Quality Assurance
Subject honoraires
Central lab

On-site monitoring

CIC recruitment strategy

Investigator recruitment: Investigators Database
Feasibility on site: evaluation of the appropriate resources and the potential patients to successfully conduct the study

Advertisements: newspapers, handbills and posters in general practitioners desks, clinics and in hospitals.
Call center, with fully trained recruitment nurses.

Proactive recruitment strategy

Communications - experience with EDC (e-CRF)

e-CRF : Specific training for all project related personnel IVRS experience
Acquisition of a clinical trial management software : « Clinsight »

Oversight for safety & protocol adherence

Procedures:

• Data and Safety Monitoring Plan
• Adverse Event Reporting
• Audit procedure

Training and education:

• Staff
• PIs

Pharmacy process

Pharmacy staff

a designated member
adequately qualified

Pharmacy facilities

Investigational Medicinal Products (IMPs)

• stored separately from normal pharmacy
• stock in an area with restricted access

Set up of study

Review each protocol
Participation to site selection and initiation visit

Pharmacy study file

Clinical trials protocol and amendments
investigator brochure
copies of documents from relevant regulatory authority
pharmacy signature list
monitoring visit log
receipt and return of IMPs
code-break
contact number of monitor, investigator…

Specific procedures