clinical development from phase I to phase III

Assistance of our experts for a project fully mastered

Optimized clinical development plan

Adapted design proposal and feasibility evaluation of your studies: keys of success

Upstream study feasibility ensures the high quality of your studies, and the respect of your timelines and budget. For this purpose, we offer you:

• Scientific discussions to better define your objectives
• The advices of our experts and teams in charge of the non-clinical and clinical development (design, sample size, pharmacodynamic tools…)
• To share 25 years of experience in clinical development (study objectives, healthy subjects / patients recruitment, investigators, regulatory requirements…)
  
  

Following these discussions, we offer you an operational feasibility to ensure the quality of your project and the respect of your timelines:

• Sites and Investigator identification in line with the objectives of your study and / or the pathology being studied
• Pre-selection of the potential sites based on specific feasibility questionnaire for your study, and site evaluation visits
• Selection of study centers based on questionnaires, sites expertise and professionalism, experience with Forenap
  
  
  

Ethical and Regulatory Affairs : The guarantee of the compliance of your project

Speed up your study start up by anticipating the regulatory constraints

The drug/device clinical development is strictly regulated by the clinical trial regulation of each country. Our Ethical and Regulatory Affairs department ensures the compliance of your project to the applicable regulation throughout its development and implementation phases. 

• Submission of your project to the different authorities to enable a study start at the earliest possible:  submission dossiers preparation, answers to competent authorities/ethics committees’ queries, fees payment, insurance…
• Management of the regulatory requirements before study set-up on investigator’s site: investigator and hospital’s contracts, notifications to local institutions…
• Regulatory follow-up during the trial execution: amendments, notifications to regulatory authorities…
  
  
  

An entire department dedicated to volunteer recruitment

Forenap recruits for you

Insomniacs, migrainers, diabetics... Our recruitment service is competitive in enrolling specific populations. Amongst the 15 000 healthy volunteers of our database, our recruters have been able to characterize 8 000 volunteers with a specific profile and build a loyal relationship with them. This is the key for a quick, effective and precise candidate selection.

Clinical phase : an optimized project management

Guaranteed timelines, controlled costs

For each study, a clinical leader manages the whole study and works closely with your teams:

• Single contact, with high operational competence to guarantee the quality and timelines of your studies.
• Involved in drafting (protocol, information leaflet, ...) and review (CRF, statistical analysis plan ...) of all study documents, ensuring an acute scientific and operational knowledge of your clinical trial.
• Coordinates the different teams involved in the study.

 At Forenap, the clinical leader is a specialized actor of your clinical trial.

Data management: a rigorous and well-tested process

Two watchwords regarding our data management protocol: security and reliability

The data collected during clinical development are reviewed systematically by our Data Management department. Control, cross-checking, sorting, encoding; informations are processed and checked before finalizing the database:

• Design of the case report forms (CRF) in accordance with the customer,
• Writing of data management plan,
• Creation of the database and entry interface in the information system,
• Coding of consistency checks and quality control,
• Independent double data entry,
• Loading of electronic data in the database,
• Control of data consistency, generating and monitoring of DCFs,
• Codification of medical terms,
• Writing of the data management report,
• Database freezing,
• Data transfer to the sponsor.
  
  
  

Statistical results for an informed decision

Operability and relevance

Our Biostatisticians work closely with the physicians, experts and clinical leaders in charge of the clinical studies. By combining methods of analysis and statistical tools, they provide you with the key elements you need to take your decisions.

• Creation of randomization codes,
• Proposal of adapted statistical analysis,
• Writing / review of the statistical part of the protocol,
• Coding of individual data listings, tables and graphs,
• Exploratory and validating statistical analysis,
• Development of statistical tools,
• Quality control.