ACPS-Network is a science-based CRO that provides customised services for the early clinical development of new drug substances and drug products
ACPS-Network is a science-based CRO that provides customised services for the early clinical development of new drug substances and drug products
There are many ways to meet complex challenges. Some are wrong, some may prove right. But there is one way that suits you best …
Learn MoreClinical trials (CT) are the ultimate test of a development hypothesis. They ought to serve a tangible worthwhile purpose. It would be a waste if they don’t …
Learn MorePharmacovigilance of clinical trials is distinct from that for authorised products. It hast its own rules and thus requires its own dedicated expert solutions …
Learn MoreGood people get better if they are encouraged to jump beyond their self-imposed limits …
Learn MoreThe brilliance of an argument is measured by its impact; its impact depends on how it is communicated …
Learn MorePrecious, but free of charge writings, readings, links, tips & tricks in the field of CT-management, GxP-Compliance, CT-Pharmacovigilance, Applied Clinical Pharmacology, …
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EMA/15975/2016 (“Guideline on GCP compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of …
Authorization of multi-origin (generic) drugs is based on the argument of equivalence vs. the originator. To this purpose. clinical therapeutic equivalence studies …
Pharmacovigilance (PV) of authorised medicinal products is regulated by a series of regulations, directives, laws and guidelines. These rulings do not relate …