The group MEDISCIS manages an ensemble of independent Clinical Research Organizations (Larime, Cémax, and C&T Paradigm) and the Biometrics firm Theriamis with established competencies in Clinical Phase I-IIa Trial Management, Bioanalysis and Biometrics (Phase I-IV). MEDISCIS manages its fully equipped clinical facilities in France (Rouen, Lagord, and Poitiers) and Belgium (Antwerp) under the highest quality control processes; all business activities take place in a GCP and GLP environment (grade A). Project management expertise encompasses every stage of trial management: Protocol Writing and Ethics Committee Submissions, Trial Preparation, Execution & Monitoring, Bio analysis, Biometrics to writing finalized reports.
Clinical Studies
MEDISCIS offers a 90-bed total capacity across its 4 clinical units with top level pharmacodynamic test expertise and equipment.
Study Types include:
First in man (combined single and multiple-dose escalation)
Pharmacokinetics (including complex interaction trials)
Pharmacodynamics (including Proof of Concept, QT prolongation trials)
A 1st rate volunteer database gives access to a large pool of study candidates (men/women) including healthy volunteers (young and elderly), post-menopausal women, and study specific population groups covering many therapeutic areas: Asthma, COPD, dyslipidemia, hypertension, type II diabetes, and Parkinson’s disease.
Bio analysis
A technical team of dedicated Chemical Engineers and Technicians within the MEDISCIS Group oversees bio analytical studies conducted using up-to-date technology and equipment: HPLC, GC-MS, LC/MS/MS.
The teams’ core competencies encompass:
Development and validation of bio analytical methods
Validation according to FDA guidelines
Assays from “in-vitro” biological samples
Pre-clinical and clinical studies
Biometrics
The biometrics team offers a full range of services including Phase I-IV and pharmaco-epidemiological data management, statistical analysis, reporting, and data management and statistical consulting services. A non-exhaustive list of our capabilities includes:
Data Management:
Case report form (CRF) design, database design and study set-up (MEDISCIS standard, Sponsor standard, CDISC), data management book (DMB) editing, double data entry (independent with audit trail), data validation, query management, coding (MedDRA®, WHODRUG®, Sponsor dictionaries), quality control, database lock, etc.
Biostatistics:
Statistical Analysis Plan writing, evaluation and analysis programming with SAS®, and the production of statistical appendices following statistical analysis plan and ICH recommendations or Sponsor specifications.
Electronic Data Capture:
An internally developed and validated trial automation and date capture system - QC&T® - is adapted to each study according to sponsor-defined study parameters and database requirements. The QC&T® system is used for all studies conducted at the Belgium site and is expected to roll-out in Poitiers during Q12006.
