Operational assistance in Clinical Research: our services are tailored to your needs

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 ).

Start-Up of assistance

After defining your needs, we will organize in partnership with your clinicians team the start-up of our activity, in respect of the policies and principles of your Department.

 

We can follow your internal Standard Operating procedures (SOPs), and we will define in full partnership with the Sponsor all the trainings necessary before tasks delegation. 

 

For an optimum service, we recommend that our assistance is initiated prior to a trial initiation.

 

We can integrate our costs in the hospital contract with the Sponsor for a full cover by Sponsors.

Regulatory consultancy and Quality Management

We can provide hospitals, healthcare centers, investigating sites or any other health department in need with consultancy and operational services  on the improvement and optimization of their Standard Operating procedures (SOPs) and Inspection readiness, suitable for the needs of industrial clinical research (observational or interventional trials) :

 

• SOP writing in conformity of the ISO9001 recommendations
• Quality controls and diagnosis
• Performance measurement indicators
• Assistance in preparation of audits and Regulatory Inspections from EMA and FDA