Customised Services for the Clinical Development of New Drug Substances and Drug Products
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Applied Clinical Pharmacology Services (ACPS) is a small-size CRO that provides customised scientific, regulatory, administrative and logistic services for the early clinical development of new drug substances and drug products. These services include consulting (including SWOT-analyses and due diligence), clinical phase I-II trial management, scientific data analysis (PK, PD and PKPD), medical writing (development plans, study protocols, study reports, IB and CTD), and training.
ACPS considers its focus on content quality to be a critical asset in minimising the risk of early clinical development. Therefore, it provides services not only for self-evident regulatory requirements (bioavailability, bioequivalence, single and repeated-dose pharmacokinetics, dose-proportionality, special collectives, etc.), but also for innovative proof-of-concept pharmacokinetic, pharmacodynamic and PKPD studies (single and repeated-dosing first-in-man, proof-of-action, proof-of-mechanism, etc.) that are crucial for a well-targeted steering of development projects in their early stages (go / no-go decisions, competitive profiling, etc.).
Clinical development consulting
Together with the sponsor's in-house experts we select the best way to plan, implement and complete a successful early clinical development effort. As part of our clinical development consulting service, we review your case meticulously, analysing its strengths and weaknesses in order to identify how to maximise your chances of success in early clinical development.
Clinical trial management
ACPS does not maintain its own trial clinics but collaborates closely with well-qualified clinical investigators, bioanalytical laboratories and biostatistical experts in the western, eastern and south-eastern EU. In addition, ACPS has recently been collaborating with well-selected sites in India.
Third parties are selected according to the most stringent quality criteria in order to establish a team that will provide a highly cost-effective and time-efficient study conduct.
ACPS provides this support either as a full-service agreement or as a partial service depending on the sponsor's specifications. The project is headed on-site at all times by an experienced senior scientist from our team, and we provide expert support for the installation of specific study methods and test procedures on-site, including investigator training and method validation.
Biopharmaceutical trial management services
ACPS's biopharmaceutical trial management services include:
- Bioequivalence feasibility assessment based on in-vitro biopharmaceutical properties; review and analysis of in-vivo / in-vitro correlations
- Single and repeated dose ('average') bioavailability / bioequivalence (BA / BE) trials
- Three and four-period replication designs (including 'population' and 'individual' BA / BE)
ACPS also provides trial management services in the field of biosimilars, including review of physico-chemical fingerprinting and biological profiling data, phase I-II (PKPD) bridging studies, and design of suitable phase III scenarios.
Clinical phase I-II trial management
ACPS offers a range of clinical phase I-II trial management services. For early phase I trials ACPS offers:
- First-in-man studies
- Single and repeated-dose studies with stepwise increasing doses in healthy men and women
- Absolute and relative bioavailability
- Food-drug / formulation interaction
- Dose-proportionality and accumulation kinetics
For later-stage phase I trials ACPS can perform proof of mechanism and action studies, single and repeated-dose drug-drug interaction(s), thorough ICH E14-compliant QT / QTc-studies, and studies in genotyped and phenotyped subsets.
ACPS offers proof of concept and dose-finding studies, as well as PK, PD and PKPD in special populations (those with renal and hepatic dysfunction, the elderly, etc.) for phase II trials.
Medical writing services
The impact of science is best measured by the way it is being communicated, i.e. by the ability to summarise complex information precisely and concisely, in accordance with the respective formal guidelines, but with a clear objective well in focus.
We provide expert medical writing services for writing study plans, study reports, investigator brochures, regulatory submissions, CTD summaries and overviews, development plans, study protocols, IB, etc.
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 (PK, PKPD and PKPD) according to the specific needs of the sponsor.
Additionally, we can provide special coaching and training of investigators and study staff in general and study-specific topics relevant to the orderly conduct of our studies.
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.