CASE STUDIES

Pharmaceutical laboratory: evaluate the effect of a pharmaceutical product by means of a clinical study

Set up and lead a prospective, multicenter phase IV clinical trial

Writing study synopsis, protocol, CRF, etc.
Regulatory declarations
Recruitment of study centers and ad hoc documentation management (conventions, etc.)
Qualification and monitoring of centers by our CRAs (30 centers over 4 years)
Implementation of an eCRF and data management (CDISC format)
Writing statistical analysis plan, SAS programming and analyses
Writing statistical and clinical reports

Medical Device Manufacturer: Post CE marking monitoring and clinical follow-up of patients with the implanted medical device

Set up and lead a PMCF (post marketing clinical follow-up) and patient recurrence evaluation study.

Writing the study synopsis, protocol, CRF etc.
Regulatory declarations
Recruitment of investigators and ad hoc documentation management (conventions, etc.)
Creation, printing and distribution of patient/investigator records, data entry and management
Writing the statistical analysis plan, SAS programming and statistical analyses
Writing the PMCF report

Nutrition: evaluate the effect of therapeutic education on overweight patients

Develop and apply a statistical and medical analysis method for a non-randomized study

Writing a study protocol and calculating the sample size
Writing a statistical analysis plan including use of the propensity score
SAS programming and statistical analysis
Writing and submitting a scientific article

Diagnostic test manufacturer: CE marking of an algorithm for diagnosing tumor progression

Develop a clinical evaluation strategy for the CE marking of an image-processing algorithm

Writing a study synopsis and protocol that meet the specificity and sensitivity constraints of the diagnostic test
Calculation of the sample size
Regulatory advice

Hospital: diagnostic test for rare lung disease

Develop and demonstrate the reliability of an automated measurement system for a diagnostic evaluation test for a disease

Writing a study protocol for the system developed by Soladis Connect
Implementation of experimental tests
Statistical and clinical validation of the measurement system

Biotechnology: phase II clinical study

Determine the dose-response relationship and dosage to be used during a subsequent study phase for comparing the drug to placebo

Writing a study synopsis and protocol including adaptive designs
Management of study data (DMP, DVP, DR , queries, etc.) and medical coding
Interim statistical analyses and redesign of study based on results obtained
Statistical and clinical reports