Contract Clinical Research

Mednavigator® is located in Berlin and offers freelance services for clinical trials in the phases I to IV in the areas listed below. German, English as well as the specific medical language are known on mother tongue level, and the activities are therefore directed internationally. Qualification with CV, indication experience, and cost estimates are available upon request in both languages.

Clinical supply management:

Ordering of the supplies for clinical study drugs in international studies from the planning stage to delivery at the sites
Manufacturing and budget planning
Consulting of study managers on packaging designs and ordering procedures
Label creation according to Annex 13 and GCP guideline; review of study drug label texts
Preparation and conduct of clinical supply meetings
Coordination of orders at external packaging suppliers and logistic partners
Supervision of all labelling and packaging steps until release and collection of all necessary documents according to GMP
Preparation of orders for foreign countries; collection and shipment of mandatory documents
Ensurance of providing clinical study drugs within stipulated time frame

Clinical study logistics with adherence to Good Distribution Practice

Distribution set-up for international clinical trials
Development of best packaging concept and testing profiles for shipping solutions
Identification of most suitable temperature monitoring strategy available
Quote negotiations in knowledge of price structure of key suppliers
Support in establishing templates of import and shipping documents
Optimisation of temperature-controlled shipments to depots and sites
Transportation and storage management; site support for cold chain solutions
Complete deviation and complaint handling; corrective and preventive action

The new IATA label for temperature-controlled drugs:

The new IATA label for temperature-controlled drugs

Monitoring

Recommendation and selection of investigators
Prestudy visits with evaluation of potential patient numbers and equipment
Collection of all necessary documents according to GCP
Initiation visits and continuous training
Primary contact for active sites without office time limitation
Monitoring visits in agreed frequency with fast and detailed reports
Support of investigators in SAE and SUSAR initial and follow-up reporting
Close-out visits with preparation of archiving

Project management

Status reports
Recruitment evaluation
Cost planning and budget control
Offer of additional capacity with freelance partners
Audit preparation

Regulatory support

Writing and checking of patient information
Obtaining patient insurance
Preparation of submissions to Ethics committees
Registration and cancellation of participating investigators at the local authorities
Updates of investigator brochures

Translations

Protocols, CRFs, patient information sheets and informed consents
Ethics committee, authority and site correspondence
CRF entries