Management of Investigational Medicinal Products 
Clinical Trial Logistics
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Logistic Support

Management of Clinical Trial Materials and Documents

Research & purchase of material

Théradis Pharma researches and purchases material depending on the study and budget requirements. The final choice of the material to be used is given to the client.

Material reception

Once the material is received it is verified and entered into a stock management database.
The verification procedure is project specific and depends upon the material received.

Material preparation

The programming of , the preparation and assembly are carried out according to the instructions which are material or document specific and have been approved by the client. Throughout, the validation steps put in place guarantee the quality of the finished product.

  • Programming of ECG apparatus,
  • Kit assembly of all kinds : sampling kits , or transport kits
Document management

Case Report Forms, patient informed consent form, information form, patient diaries, operating manuals, instructions, brochures, pre-paid envelopes...

  • Logo Conception
  • Numerical, offset printing
  • NCR paper: duplicate, triplicate, quadri etc
  • Numerotation : stamping, perforation, codebar
  • Quadri colour documents
  • Preparation of documents for expedition
  • Large scale sending : mailing

Printing of documents is either carried out in house, or, for larger volumes, a printing company is selected. The assembly of the required documents is established with this company and verified, quality control procedures are established as well as the follow up of the printing schedule.

Preparation of packaging and shipment

The preparation of the shipment is requested  by the project team (by fax, email or interactive voice response systems) and is carried out by the logistic technicians.

Each package to be shipped is checked by a second technician and the shipments details are entered into the stock database, allowing the tracing of it’s movements.

The packaging material used (size and resistance of the outer packaging material, use of blocking material) is determined according to the type of material to be transported and the country of it’s destination.

Storage
  • Capacity and duration of storage adapted to requirements
  • Dedicated and secure zones reserved for each project, client and specific to the product stored
  • Storage conditions at all temperatures
  • Data entering, regular follow up and verification of stock
Return

Theradis Pharma organise material return at the end of a study, for destruction or return to the client. Each return is entered into a database and the material or documents received are verified and accounted for.

Supply and resupply of centres (distribution)

The supplying of the Investigator centre is carried out according to the study’s requirements and the capacity that the centre has for storing the material.
Theradis Pharma traces and follows up each shipment and confirms the shipment’s delivery.

Centralised management

All movements of material are traced. Status tables relating to the material’s movements are permanently available for the client, as well as an update as to the stock available.
Remote data access by client and by project is made available through internet.