CCDRD has more than 26 years of experience in planning and performing different clinical trials. Our team takes care of all steps from initial trial planning and feasibility evaluation over provision of all trial-related documents, submission and insurance service, site and overall project management, monitoring , sample shipments to the provision of the final clinical trial report. Before initiating the trial, we advise our clients with regards to regulatory considerations and strategy, including interaction with target authorities. After completing a clinical trial, CCDRD´s experts answer the potential questions of regulators during the marketing authorization procedure.
Scope and capabilities:
- Phase I trials performed in one of our phase I units in Bulgaria, Turkey or Jordan
- Pharmacokinetic trials in healthy volunteers
- Pharmacokinetic trials in patients
- Bioavailability and Bioequivalence trials
- Therapeutic equivalence studies
- Inhalatory trials with pharmacokinetic and clinical endpoints
- First in men studies
- Phase II-IV trials in all major indications such as oncology, renal disease, CNS, diabetes, dermatology, ophthalmology
- Immunogenicity trials
- Adhesion and sensitization studies
- Complete study packages for biosimilar drug registration
- Registration packages for medical devices
- Non-interventional phase IV trials