ACPS Customised Services for the Clinical Development of New Drug Substances and Drug Products
Applied Clinical Pharmacology Services (ACPS) is a contract research organisation (CRO) that provides customised scientific, regulatory, administrative and logistic services for the early clinical development of new drug substances and drug products.
The company offers a wide range of consulting services, including strengths, weaknesses, opportunities and threats (SWOT) analyses and due diligence, alongside clinical trial management, scientific data analysis, medical writing and training offerings.
ACPS also creates regulatory clinical documents such as development plans, study protocols, study reports, investigator’s brochures (IB), scientific advice briefings and common technical documents (CTD).
Clinical development and regulatory consulting
Together with the sponsor’s in-house experts, ACPS selects the best way to plan, implement, complete and report a successful early clinical development effort.
In addition, the company provides expert support on how to construct and defend the best possible regulatory case.
As part of its clinical development and regulatory consulting services, ACPS reviews its clients’ cases meticulously, analysing strengths and weaknesses to identify how to maximise the chances of success.
Clinical trial management
ACPS does not maintain its own trial clinics but collaborates closely with well-qualified national and international clinical investigators, bioanalytical laboratories, pharmacometric and biostatistical experts. Third parties are selected according to the most stringent quality criteria to establish a team that will provide a highly cost-effective and time-efficient study conduct.
ACPS provides clinical trial management support either as a full-service agreement or as a partial service depending on the sponsor’s specifications. Projects are headed on-site at all times by ACPS’ experienced senior scientists, and the company provides expert support for the installation of specific study methods and test procedures on-site, including investigator training and method validation.
For clinical Phase I-II trials, ACPS provides customised A-Z services from trial design and protocol conception to trial reporting and European Clinical Trials Database (EudraCT) uploaded in various fields, including single and repeated-dose first-in-humans studies; biopharmaceutical studies such as bioequivalence/bioavailability and drug-food interaction; dose-proportionality and accumulation properties; drug-drug interaction; special collectives such as hepatic, renal and elderly; assessment of exposure-response relationships; dose justification and proof-of-concept in the target population.
For clinical Phase III trials, ACPS provides customised services for central clinical trial coordination, quality management, pharmacovigilance (including set-up and management of data safety monitoring boards), investigator training and support (including set-up of trial-specific interactive webpages), and regulatory compliance, including electronic trial management file (TMF) management.
Medical writing services
ACPS provides customised services for medical writing, including SWOT reports, IBs, clinical trial protocols (CTP), clinical trial reports (CTR), periodic safety update reports (PSUR), regulatory overviews (M2.4 and M2.5), regulatory summaries (M2.6 and M2.7), regulatory briefing documents, monographies and publications.
Pharmaceutical clinical pharmacology training
The success of any development effort depends on the expertise and competence of the collaborating parties. ACPS provides off-site and on-site customised teaching and training in pharmaceutical clinical pharmacology, including pharmacokinetics (PK), pharmacodynamics (PD) and pharmacokinetic/pharmacodynamic interrelations (PKPD).
In addition, ACPS provides special coaching and training for investigators and study staff in general, as well as study-specific topics.
In 2017, ACPS developed a new website to showcase its high-quality, custom services for the early clinical development of novel medicinal drug products and substances. It features a wide range of writings, links, tools, tips and tricks that the company shares for free.
Called the ACPS Library, this resource is a continuous project that regularly updated and extended. The company also listens to user feedback, comments and suggestions.
ACPS was founded in 1997 and is headed by associate professor Dr Christian de Mey, who has more than 30 years’ of hands-on experience in applied clinical pharmacology in academia, the pharmaceutical industry and contract research.
With more than twenty years’ experience in managing clinical trials, ACPS provides expert, cost-effective services that meet the highest formal quality standards.
Products and Services
Clinical Trial Management
ACPS relies on more than 20 years of hands-on experience in providing dedicated customised high-level services for the cost and time-efficient planning, conduct, analysis and reporting of Phase I-II clinical trials. For Phase III trials, ACPS provides customised services for central clinical trial coordination such as quality management; pharmacovigilance; investigator training and support, including set-up of trial-specific interactive webpages; and regulatory compliance, including trial master file (TMF) management.
Clinical Trial Pharmacovigilance
Pharmacovigilance (PV) in clinical trials is an inherent aspect of good clinical practice (GCP). Although relying on the processes and resources put in place by the sponsor for EudraVigilance reporting, PV of clinical trials requires its own GCP-compliant trial specific provisions. ACPS provides dedicated customised services for the set-up, management and reporting of orderly GCP-compliant PV of early clinical trials in the EU, including initiation and management of data safety monitoring boards.
Teaching and Training
Continuous training is a good clinical practice (GCP) mandate. ACPS provides customised services for teaching and training that help its trainees understand not just how to do things, but why we do things in a certain way. To this purpose, the company has created a series of training modules on clinical pharmacokinetics, bioavailability and bioequivalence, pharmacovigilance for clinical trials, GCP, and good documentation practice (GDP) compliant trial master file (TMF) management.
ACPS provides customised services for medical writing, including gap and strengths, weaknesses, opportunities and threats (SWOT) reports, investigator brochures (IB), clinical trial protocols (CTP), clinical trial reports (CTR), periodic safety update reports (PSUR), regulatory overviews (M2.4 and M2.5), regulatory summaries (M2.6 and M2.7), regulatory briefing documents, monographies, and publications.
Consulting and Regulatory Services
ACPS provides customised expert services for the set-up, review and improvement of the development and regulatory strategy of novel drug products aimed for marketing authorisation in the EU, including due diligence; gap analysis; strengths, weaknesses, opportunities and threats (SWOT) analysis; scientific advice; centralised procedure (CP), decentralised procedure (DCP), mutually recognised product (MRP); and documentation creation according to EU Directive 2001/83/EC).
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