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Contact : Christophe Soyez (Founder & Executive Manager)
Having spent about 20 years as CRA and then as Clinical Trial Manager I have had the chance to get a global vision of biomedical researches (clinical, observational …) from study concept to the communication of the results.
During this period of time, I had to deal with recurrent issues usual structures of laboratories or CROs couldn’t provide efficient answers. These issues induced (and still do) an extension of study timelines, a quality of data that still can be improved, potentially hectic relationships between all involved people … All this into a highly challenging international environment.
To face this, Medi-Link brings you an innovative answer by using qualified local personal, providing an adaptive and optimal support to investigators’ dedicated local teams.
- Recruitment of investigators,
- Realistic study feasibilities (timelines, volume and costs) performed among investigators’ sites,
- Support for French regulatory submissions,
- On-site investigator’s support to:
- Ensure the respect of timelines and budget (from site and patients recruitments to the database cleaning and/or safety activities …),
- Enhance qualitative and quantitative sites and patients recruitments as well as data collection,
- Reduce the number of patients lost to follow-up or data lost.
- Ensure collection of high quality data, including for Post Authorization Surveys (PASS, PAES …)
- Provide Councils to the investigators and their team to optimize site activities.
- Support the sites during monitoring activities, Audits, …
- Ensure archiving of study documents in secured areas at the end of the study,
- Train the investigators and their teams to maintain technical and regulatory skills of the investigators up-to-date,
Added value for the sponsor:
- Reliability on the investigators and study teams,
- Optimization of site recruitment and management,
- Guaranties on the: Data quality, Getting real patients (epidemiology), Study timelines & budget …,
- Reduced monitoring workload (time and number) and their costs,
- Access to a new pool of investigators,
Tags: étude post-inscription, études de soins courants, études épidémiologiques, études pharmaco-économiques, Phase 2, Phase 3, Phase 4, Etudes de marché, Sondages, Economie de la Santé, Marquage CE, TECs, Expertise Méthodologique, Formation investigateurs, Médicament, Dispositif Médical, Biotechnologies, Cosmétologie, Nutrition