Clinical & Medical Development
Diapharm
is a full-service provider for all aspects of clinical development and medical affairs.
We advise in all aspects of
pharmacovigilance, including PSURs and pharmacovigilance systems. We
assume responsibility for serving as the qualified person for
pharmacovigilance and the information officer, and we prepare
pre-clinical and clinical expert reports.
Or perhaps you lack the resources to conduct a clinical trial or a post-marketing surveillance study?
For the field of clinical
research we assume project management responsibilities for phase I to IV
trials and conduct post-marketing surveillance studies (PMS) on your
behalf. We prepare the schedule and the case report form (CRF) and take
charge of data management.
Our services in this area include:
Medical Writing
We prepare expert reports
on clinical particulars and pharmacology / toxicology as part of the
marketing authorisation procedure and for borderline projects.
We assume all project management
responsibilities for your projects in the area of clinical research.
Pharmacovigilance systems
We relieve you of all of the obligations associated with pharmacovigilance and risk management.
We prepare a submittable PSUR (Periodic Saftey Update Report) for your medicinal product. Alternatively, purchase one of our already prepared API-specific PSUR.
We act in the capacity of the qualified person responsible for pharmacovigilance (QPPV) as stipulated in directive 2001/83/EC
Function as information officer
We act in the capacity of the information officer as stipulated by the German Drug Law (AMG).
