- Phases I , II, III and IV (post marketing approval)
- Project Management
- Clinical Monitoring and Co-monitoring
- Regulatory Affairs
- Timelines and Budget Control
- Site Management
- Veterinary Clinical Trials
- Clinical Trials with medicinal products of chemical origin
- Clinical Trials with biotechnology compounds including medicinal products containing genetically modified organisms
- Bioavailability/Bioequivalence Clinical Trials
- Clinical Trials with medical devices
- Special Population Clinical Trials
The Clinical Project Management is a crucial part of a study’s success. We carefully develop our team to ensure we can assign experienced project managers with proven expertise in clinical research to your project.
Our clinical monitors are trained and experienced to ensure the efficient delivery of high quality data. With continuous training in GCP-ICH as well as specialized training in various therapeutic areas, our goal is to assign experienced, locally based monitors familiar with local customs and regulatory requirements.
With the adoption of improved technology and clinical operations processes and our proactive risk prevention and management, we can offer Risk Based Monitoring services for your research program.
At MEDResearch we understand the needs of our customers and the importance of sound regulatory strategies within a complex and ever-changing environment.
MEDResearch's rich experience in regulatory submission is an invaluable tool in following timelines and avoiding delays.
Controlling development timelines and budgets is essential for companies which want to bring a product to the market. MEDResearch provides you with all the information necessary in order to keep you informed and stay in control of the process, every step of the way.
Our extensive experience and knowledge can assist you in:
- Protocol development and writing
- Investigator’s brochure development and writing
- CRF and eCRF development (also printing and distribution)
- Monitoring manuals
- Translation services in all local CEE languages
- Medical marketing scripts
- Graphic displays & slides for scientific or Corporate meetings
In addition to our internal expertise, you can get direct market feedback through meetings with panels of clinical experts.
We offer continuous support to the investigational sites, addressing key aspects such as (but not limited to): comprehensive protocol discussion and understanding, potential recruitment strategies, adequate site training, scheduling of project activities, expedited AE/SAE reporting, team of site coordinating specialists will ensure the advancement of your research goals, providing efficient site services and recruitment.
With Veterinary Clinical Trials being a big part of the clinical research spectrum, we decided long ago to offer services in this area as well. Over the years we gained expertise and experience and to this date we can provide services such as (but not limited to) Overall Study Set up, Planning and Strategy development, Dose finding, Dose confirmation and Field efficacy studies. By proper site selection, monitoring, data processing administrative control we can lead your research program from the beginning to its successful completion.