OUR SPECIALIZATIONS

Soladis Clinical Studies has been the clinical research CRO subsidiary of Soladis since 2015, when the group acquired Orgamétrie.

Founded in 1992, initially as a network of investigators led by Dr. Pierre Clerson, a doctor with a passion for biomedical research, the company grew brick by brick to expand its range of expertise and meet all its clients’ needs.

Centered on strong medical expertise, the structure of our team has gradually developed to encompass the additional activities required to carry out and coordinate clinical trials:

• Dedicated project management, keeping of Trial Master Files and Center Specific Files;
• Management of administrative and financial aspects of the project;
• Study methodology and design: writing the study synopsis, the protocol, the CRF, the patient information sheet and more generally all study documentation;
• Regulatory declarations (French National Agency for Medicines and Health Products Safety, Ethics Committees, French National Commission on Informatics and Liberty);
• Recruitment of investigators/observers and management of study documentation (contracts, agreements, kits, CRF, patient diaries, etc.);
• Qualification and monitoring of study sites by our CRAs;
• Vigilance : gathering, following and reporting of AE/SAE ; reporting of SUSARS ; drafting the DSUR;
• Data acquisition: e-CRF or double data entry by our operators (Clinsight/Ennov Clinical) in CDISC format;
• Data validation: data management, query management;
• Statistical analyses (SAS and R) from our Soladis STATISTICS team;
• Writing statistical and clinical reports (ICH format);
• Exploitation of results: abstracts, posters, research articles.

These activities are carried out in France and throughout Europe thanks to our netword, in compliance with the applicable regulations (ANSM, EMA, FDA, etc.), meet the expected standards (ICH, CDISC, etc.) and are subject to our quality assurance procedures.

Our clients – pharmaceutical laboratories working in human or animal health, biotechs, medtechs, cosmetics companies, nutrition companies and institutions – benefit from the expertise of our team of some fifteen employees, whose work has been recognized by the medical and scientific communities through the publication of almost 90 articles in international peer-reviewed journals (New England Journal of Medicine, JAMA, Arthritis and Rheumatism, etc.).

In our work managing interventional, observational, epidemiological, bibliographical and medico-marketing clinical studies, we aim to bring an innovative perspective to each study, combining:

• novel ideas (personalized or precision medicine, genomics, adaptive designs, etc.),
• analysis methods that go beyond the basics (construction of composite criteria, propensity score, Bayesian analysis, etc.),
• analogue and digital data capture solutions that we can develop to enhance studies, working with our Soladis CONNECT and Soladis DIGITAL teams.

Over the years, we have developed exceptional proficiency in managing studies of rare diseases and multi-system diseases, as well as real expertise in the fields of pulmonary hypertension, scleroderma and lysosomial diseases.

More generally, we currently cover the following areas: Pain relief, Neuropsychiatry, Respiratory medicine, Immunology, Reproductive biology, Dermatology, Ophthalmology, Allergies, Implants, Hypertension (coronary artery disease), Asthma, CNS (epilepsy, Alzheimer’s, MS, etc.), Gastroenterology (UC, Crohn’s), Internal medicine (Scleroderma, pulmonary hypertension, Gaucher’s disease, etc.), Infectious diseases (HIV, antibiotics), Diabetes, Contraception, Rheumatology, Lipidology and more.