Operational assistance in Clinical Research: 

we anticipate site related issues with an "on demand" risk based approach 

Senior profile, the Clinical Research Coordinator (CRC, or Study Coordinator) is the right-hand man of the Investigator during the whole performance of a clinical trial.

 

This fonction is not common in France, and this type of assistance is particularly suitable for healthcare departments with low or medium sollicitations for industrial researchs (such as paediatry, orphan diseases, etc...) or the departments where a full operational trial team is not available.

 

The CRC can handle :

• industrialtrials operational preparation
• review of budgets and implementation of contracts
• participation to investigator's Meetings and review of the protocol
• implementation of specific tools dedicated for the trial
• on site and remote administrative management of patients 
• admissions preparation
• visits schedule
• phone contacts
• shipment of the appropriate documentation
• patient selection and recruitment process
• patients screening
• informed consent process involvment and explanation of the organizational and non medical aspects of the trial
• inclusion/exclusion criteria verification
• follow-up of patients enrolled in trials and performance of non invasive medical acts
• review of adverse events
• involvment in serious adverse events declaration process
• participation in patient consultation and interviews (does not substitute a medical consultation by an investigator)
• administration of questionnaires (QoL, etc...)
• PRO review
• initiation and programmation of patient materials (eDiaries...)
• all other evaluation delegated by an investigator (such as and not limited to walk tests, vital signs collection, etc...)
• biological samples management
• preparation of samples (centrifugation, transfers...)
• shipment to central laboratory
• management of IPs (in partnership with the Pharmacist)
• IWRS acts
• accountability
• source documentation management
• writing of specific reports (secondary sources) to optimize reading and interpretation of primary data during monitorings and follow-up by third parties (such as GPs)
• documentation organization
• archiving
• data collection
• CRF completion
• queries management
• preparation and participation to monitoring visits, audits and regulatory inspections 

All our interventions are performed in respect of Good Clinical Practices, local and international regulations and recommendations (such as Public Health Code...), and in particular the ICH Efficacy, and the essential duties of Clinical research Coordinators as definied by the Association fo Clinical research Professionnals (ACRP : www.acrpnet.org ).

Quality Assistance

We assist Pharma companies on Quality Management Systems optimization and compliance:

 

• Writing, review or updates of Standard Operating Procedures (SOPs)
• Training of operational teams
• Implementation of quality measures and performance metrics
• Vendors management
• Non conformities management and CAPA (Corrective and Preventive Actions) implementation

 

This service can be deployed in house or remotely.

Quality Controls and Inspection Readiness

We visit investigating sites with high risk of Inspection to perform :

 

• Training and preparation of Investigators and research teams on the performance of an EMA-FDA Inspection
• Quality control of source data (monitoring oversight)
• Oversight visits
• Investigator Site Files quality controls
• Preparation of a pre inspection contingency plan

All our interventions are performed in english language and can be deployed worldwide.