Contract Clinical Research

Mednavigator® is located in South Palatine 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 and regulatory teminology in clinical research, 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 in cooperation with the following service providers under one contractual agreement will be considered with preference:

- moco monitoring & communication GdbR (www.moco.cc)

- Flying Study Team GbR (https://www.flyingstudyteam.com/en/)

- Relaion Clinical Serivces (https://www.relaion.com/)

- Gieseke Solutions (https://www.linkedin.com/in/kerstin-gieseke-393467a1/)

If required, there is the flexibility to provide additional support via the own network also in ongoing projects.

Project management

Selection, qualification and oversight of external vendors

Proposal evaluation, contract negotiations

Fesibility studies, site assessments

Risk evaluation and quality assurance on all levels

Expenses and resources planning, budget control

Audit preparation, presence at conduct and follow-up

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, also 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

Reconciliation of manufactured, released, shipped, used and expired IMPs and other clinical supplies on an ongoing basis and at the end of a clinical trial

Issue, deviation and complaint management

Development, implementation and follow-up of corrective and preventive actions

Specific experience with the interfaces for manufacturing and distribution of fresh and frozen CAR-T cells used in clinical trials for different biotech sponsors

Generation of work instructions and manuals for handling IMPs

Clinical Study Logistics

Trainings for 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

Specific experience with temperature control, shipment modalities and handling of fresh and frozen CAR-T cells used in clinical trials for different biotech sponsors

Knowledge of the working procedures of several premium couriers

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