Clinical Pharmacology

PRA’s Early Development Services group is committed to the highest standards of clinical excellence and scientific expertise. We operate state-of-the-art facilities in The Netherlands and North America as well as an innovative patient pharmacology model in Central and Eastern Europe, providing the biopharmaceutical industry with a unique scientific environment required for complex compound development and testing. In addition, PRA’s harmonized laboratory facilities in The Netherlands and the US are situated close to the clinical facilities and are configured to fully support all clinical study requirements.

The most comprehensive, high-end Phase I CRO in the world.

PRA Early Development Services live and breathe clinical pharmacology

PRA understands the need to maximize success while minimizing time and costs. We’ve developed an efficient and powerful process that demonstrates our commitment to executing studies under short timelines.

With the strategic proximity of our laboratories to our clinical research units, and the harmonization between the facilities, we can save six to 12 months on the entire Phase I-IIa development program using our Fast Track approach. Additionally, we demonstrate our market leadership through the application of technology, integration of clinical and bioanalytical services, unique access to patients with the Patient Pharmacology Services and our 95% on-time study start and completion rate.

With 30 years of experience in cooperation between sponsors, clinics and laboratories, PRA is the ideal global early development CRO to perform your bioanalytical laboratory and clinical research services.

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Pharmacology Centers

PRA’s early phase facilities employ 1,000 support staff and have a total capacity of 460 beds across seven Clinical Pharmacology Units in four different countries. Each facility offers the latest technologies, diagnostic tools and infrastructure required for the conduct of highly scientific studies across a wide range of drugs and indications. In addition to our own internal clinics, the PRA has extensive experience managing global Phase I clinical sites with healthy volunteers, including in Asia Pacific. We routinely manage third-party clinical sites through an external site management model, wherein either our European or US staff directs the non-clinical services while the third-party site generates the data.

Czech Republic
Hungary
Lenexa, KS
Marlton, NJ
Salt Lake City, UT
The Netherlands

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Pharmacology Solutions

Our global Early Development Services (EDS) teams can meet the needs of essentially any early phase study for healthy volunteers, special populations and early patient trials. From protocol design to Clinical Study Report (CSR) delivery, each clinical team can fully support a project with dedicated resources. Our GMP pharmacy can support manufacturing and Qualified Person (QP) release of any formulation of drug, including radio-isotopes to support 14C ADME and tracer labeled studies for IVPK and MIST guidance studies. Our full-service bioanalytical facility provides real-time support for PK and biomarker analysis, allowing dose-escalation decisions to be made with more than just safety data. PRA’s early phase infrastructure can provide full support to our clients and facilitate shortened timelines in early development.

Early Development Services

Solutions_Clinical_Pharmacology_Pharmacology_Solutions

Our teams excel at conducting early phase projects. A dedicated data services group supports each team, working to convert raw data into decision-point data for our clients. Our clients can be confident that the reports they receive from our teams are comprehensive, and that the raw electronic data can be delivered to them in a format you can easily incorporate in to your internal systems for future analysis. With 1,000 people, 450 beds and 8 different Phase I centers globally, PRA is poised to help make your project a success.

Drug Development Programs
Exploratory Clinical Trials
Fast Track Development
Pain Studies
Patient Pharmacology
Target Product Profile

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Phase I Healthy Volunteers

PRA Early Development Services conducts clinical trials in both healthy volunteers and patient populations and is committed to the highest standards of clinical excellence and scientific expertise.

Phase I healthy volunteer studies have always played a vital role in clinical research by producing new data through well designed studies providing researchers with new knowledge, but not providing direct benefit to study participants.

PRA’s combination of expertise and industry leading methodology enables a range of specialist studies with delicate pharmacokinetic or pharmacodynamic objectives. For our in-house Phase I studies, we accommodate volunteers at one of our state-of-the art Clinical Pharmacology Centers, where they are under constant medical supervision. Our early phase clinical research centers provide;

  • A globally harmonized service.
  • A full suite of Phase I-IIa clinical research services.
  • Experience and expertise in bioanalytical laboratory studies.
  • A dedicated and knowledgeable workforce.
  • Large pool of healthy volunteers (>40,000).
  • Study design flexibility.
  • Special equipment to monitor safety and pharmacodynamics.
  • In-house pharmacy.
  • Expedited regulatory approval.
  • Minimal timelines by excellent communication and rapid data processing.

In addition to our own internal clinics, PRA has extensive experience managing global Phase I clinical sites with healthy volunteers, including in Asia Pacific. We routinely manage third-party clinical sites through an external site management model, wherein either our European or US staff directs the non-clinical services while the third-party site generates the data.

Addiction Studies
ADME & Microdosing Studies
Biosimilar Expertise
GMP Pharmacy
Healthy Volunteer Studies
Human Abuse Liability
QTc studies
Speciality Populations

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Early Phase Patient Studies

PRA Early Development Services conduct clinical trials in both healthy volunteers and patient populations and are committed to the highest standards of clinical excellence and scientific expertise.

Because of an increased interest in having patient safety and efficacy data available as early as possible during the clinical pharmacology program PRA has invested substantially within this area to support our client’s needs.

Each of our eight clinical pharmacology centers has the capabilities and experience to quickly randomize patients, and four of our centers are 100% dedicated to early phase patient studies, both in Europe and the USA.

Within Central and Eastern Europe, PRA has established an innovative Patient Pharmacology Services (PPS) group dedicated to early phase patient studies. PPS performs early patient trials in collaboration with an extensive network of investigators in Central Eastern European countries such as Hungary, Poland, Czech Republic, and Slovakia. Centralized health-care systems with a limited number of hospitals focusing on certain diseases are characterized by huge outpatient clinics with excellent access to patient populations.

Our Clinical Research Centers in the United States specialize in the conduct and design of early stage, patient population studies, and are therapeutically focused in Human Abuse Liability (HAL), addiction, pain, psychiatry, neurology, pediatric and infectious disease services.

Our comprehensive areas of expertise range from a 16 DMII-patient panel in a multi-purpose protocol, early Proof of Concept, highly complex patients trails such as Renal/Hepatic impaired trials, ADME studies in oncology patients, to children with Tourette Syndrome.

At PRA, our established group of experts and facilities remain firm in our commitment to enrol patients into studies as early as possible.

ADME Studies in Oncology Patients
Alzheimer’s
Anxiety
Central Nervous Systems
Depression
Diabetes
HCV
Paediatric
Schizophrenia