Contract Clinical Research
Mednavigator® is located in Berlin and offers freelance services for clinical trials in the phases 1 to 4 and for non-interventional studies (NIS) with investigational medicinal products and medical devices in the areas listed below.
With German and English spoken and written on mother tongue level as well as thorough knowledge of the specific medical teminology, the activities are directed internationally. Qualification with CV, indication experience, and cost estimates are available upon request in both languages.
New assignments with an innovative therapeutic approach and up to 1.5 FTE in „tandem“ with the following service providers under one contractual agreement will be considered with preference:
https://www.moco.cc/de/unternehmen.php
Project management
Selection, qualification and oversight of external vendors
Proposal evaluation, contract negotiations
Fesibility studies, site assessments, Quality assurance in the areas listed
Expenses and resources planning, budget control
Audit preparation, presence at conduct and follow-up
If required, there is the flexibility to provide additional capacities via a network of freelancers.
Regulatory support
Translation of protocol synopses, patient information and consent forms, Ethics committees, authority and site correspondence
Generation of of GDPR-compliant patient information documents including for study participants not capable to consent by themselves
Obtaining patient insurance
Clinical trial applicaton preparation and submissions to competent authorities, Ethics committees and according to § 23b MPG; communication with these institutions
Evaluation requests to DRG and BfS submissions, if applicable
Registration and cancellation of participating investigators at the local authorities
Clinical supply management:
Coordination of continuous supply with investigational products for international studies - from planning of shipment logistics with receipt at the trial sites to return / destruction
Manufacturing-, budget- and quantity 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 and in sufficient quantities
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
Co-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