Clinical operation management
Working with different pharma companies and CROs and considering different monitoring strategies we are able to plan an intelligent and effective project specific concept which fits your needs. With more then 15 years of experience in clinical operations . From early development to Phase IV, non-intervention trials, investigator-initiated trials, clinical investigations with medical devices Addomed expertise is at our clients’ service at this important stage of clinical trial management.
Study rescue- If you are experiencing problems with your trial, let’s talk! we can help you speeding up recruitment, reviewing protocol and much more.
Addomed’s experience with the various subject populations allow us to offer highly educated and experienced project „tailored „teams. Addomed experience with the interventional and non-interventional studies provides an extensive and reliable network of the potential investigators.
We can help you with regulatory submission strategies and preparation, regulatory meeting preparation and attendance. With a broad range of therapeutic expertise collected through years, our capabilities include clinical operations management, and experience with studies from Phases I-IV.
Our experienced staff perform feasibility activities to assess site suitability and conformity
Submissions to regulatory authorities and follow-up
Negotiations of contracts and budgets
Clinical trial monitoring
Site preparation, initiation, monitoring and close-out
Site personnel training and continuous guidance
We have experience in the following therapeutics areas:
Metabolic/Endocrinology (Gaucher's disease, medical device NASH fibrosis)
Psychiatry (Schizophrenia, Parkinson's disease)
Neurology (SAH, migraine, Chronic non-malignant pain, Alzheimer disease)
Cardiovascular (Chronic Heart Failure)
Infectious disease (Clostridium difficile infection)
Immunology (Influenza- Vaccination pediatric study)
Oncology (NSCL, Breast cancer, Ovarian Ca, Melanoma, Colorectal Ca)
Rheumatology (Ischemic digital ulcers, Rheumatoid arthritis)
Respiratory (IPF, COPD)
Cardiology (Vascular diseases)
Ophthalmology (Age-related macular degeneration)