Clinical Evaluations and Reports
Our fully integrated understanding of Good Clinical Practices (GCP) and Good Manufacturing Practices means we understand the predicate controls and systems required to effectively conduct and administer a clinical program. For virtual companies this translates to understanding the minimum controls and systems required to engage and manager your CRO and clinical packager. For established organizations, this translates to knowledge and expertise that can complement your own internal resources. From early product development through post-market, we can assist our clients in every facet of their clinical program, from protocol preparation or CRO selection and IRB approval to investigator training and post-market vigilance. Our expertise is global and includes most major markets including US, Europe, Australia and New Zealand. Pharmatech also retains BIMO certified auditors, MDs and industry pharmacovigilance experts to support your GCP and GVP requirements.
Ultimately, clinical data must be summarized for regulators for review. Our medical writers are experts in presenting clinical data in clinical trial reports, safety reports and clinical evaluations. For companies who intend to demonstrate clinical evidence using literature, we also conduct targeted literature searches and reviews that present all necessary data in a well-organized, easy to follow manner.