Loading...

ACPS - Applied Clinical Pharmacology Services

INTELLIGENCE & CONSULTANCY SERVICES FOR EARLY CLINICAL DEVELOPMENT

ACPS-Network is a science-based Intelligence & Consultancy Platform
that provides customised services for the early clinical development of new drug substances and drug products

CONSULTING & REGULATORY

There are many ways to meet complex challenges. Some are wrong, more than one may prove right. But there is one way that suits you best¬†…

Learn More

Early CT Management

Site selection, site qualification and set-up of risk-based quality management systems …

Learn More

CT Pharmacovigilance

Pharmacovigilance of clinical trials is distinct from that for authorised products. It has its own rules and thus requires its own dedicated expert solutions …

Learn More

Teaching & Training

Good people get better if they are encouraged to jump beyond their self-imposed limits …

Learn More

Medical writing

The brilliance of an argument is measured by its impact; its impact depends on how it is communicated …

Learn More

ACPS' Library

Free of charge writings, readings, links, tips & tricks in the field of CT-management, GxP-Compliance, CT-Pharmacovigilance, Applied Clinical Pharmacology, …

Learn More

OUR Commitment

to bring Applied Clinical Pharmacology to the point ...

Latest from our library

Archiving – How long?

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 …

Read MoreArchiving – How long?

Bioequivalence-Testing

Authorisation of multi-origin (generic) drugs is based on the argument of equivalence vs. the originator. To this purpose. clinical therapeutic equivalence studies …

Read MoreBioequivalence-Testing

CT-Pharmacovigilance Manual

Pharmacovigilance (PV) of authorised medicinal products is regulated by a series of regulations, directives, laws and guidelines. These rulings do not relate …

Read MoreCT-Pharmacovigilance Manual