Management of Investigational Medicinal Products 
Clinical Trial Logistics
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The team

The Team and their Experience

The logistical set up required for a clinical study is much more complex than we could imagine. Having already participated in studies, or picked up samples for these studies, does not always enable the anticipation of the difficulties that can ensue for further studies.
The logistical steps that are indispensable for the correct running of a clinical trial cannot be improvised and require a global comprehension of the study components, due to the specific constraints of the project’s therapeutic area, the different actors involved, the location of the centres changing etc.

 Due to their intervention in hundreds of studies of all types, set up in France as well as throughout the world, during 20 years in the heart of French CROs and then global companies, the Theradis Pharma team has acquired an uncontestable experience of the logistics that are specific to clinical trials.
Welded by their experience of working together for many years, the team has an excellent knowledge of the regulatory environment and the demands of clinical trials.

This team was constituted in 1992 in the midst of an International Service Company. The Company was renowned for delivering quality service, which constructed it’s excellent reputation and developed an elevated client satisfaction rating.

The profile of studies already managed by Theradis Pharma are extremely varied :

  • Studies set up in France within a hospital environment  for which the training and supplying of the different participants was involved.
  • Studies carried out outside the hospital environment, in different towns in France, involving the synchronization of a multitude of participants, (GPs, Specialists, Local Laboratories, Radiologists, taxi services…), taking in charge the patients, data collection and entering (vital signs, help with dosage..)
  • International studies set up in countries with an infrastructure ready to operate, as well as in other countries requiring that the logistics be adapted entirely to the local means. 
  • Global studies necessitating the set up of local relay-platforms, the establishment of very specific logistics etc.

For these studies, the Theradis Pharma team have carried out all types of logistic support services for clinical trials, such as the management of IMP, management of study material and documents, biological logistics (centralisation of analyses) etc.

Examples of studies carried out :
  Phase Length in months N° Countries Location N° of sites N° of patients Characteristics/service complexity
Material Management III - 18 Europe, Eastern Eur, Australia, Sth America, Africa 292 8760 Multi sites - multi continents
- - 7 Europe 7 4450 Management of complex material
Printing and management of documents - - - Nth and Sth America, France 3 1000 3000 CRFs sent to 3 different warehouses
- - 1 France 1500 15000 Management of survey documents
Biology Logistics III 12 3 Europe 350 1900 Biological monitoring of 4700 profiles and management of 30 Local laboratories  and Nursing surgeries
III 54 6 Eastern Europe 23 430 1076 profiles – Management of biological sample pick up
III 18 12 Europe 100 918 3325 profiles – management of 22 Local Laboratories and Nursing Surgeries
Management of IMP II 14 3 Eastern Europe 16 360 Refrigerated shipment of IMP to Eastern European countries
IV 8 1 France 2000 6000 Grouped shipments up to  300 shipments/day
II 11 7 Europe and Eastern Europe 29 308 Several sites per country – Ambient shipment
III 18 11 Europe and Eastern Europe 71 1471 Multi sites - multi country