Clinical Pharmacology

Meet Randall Hein (Vice President, Early Development Services)

Proven Expertise in Early Development Studies

Through PRA's harmonized clinical and laboratory facilities in The Netherlands, the United States, and Central and Eastern Europe, PRA offers over 220 beds worldwide. We have equipped each clinic with the technologies and infrastructure needed for high quality, efficient studies on a wide range of drugs and indications. In addition to routine early phase studies, PRA specializes in more complex, first-in-human studies. PRA has developed extensive methodologies enabling us to conduct 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.

PRA's Early Development Services include:

First-in-human studies
Single and multiple dose safety and tolerability studies
Patient phase I studies
Proof of concept studies
Interaction studies with drugs and food
Single and multiple dose bioavailability studies
Bioequivalence studies
Mass balance/ADME studies
Microdosing studies
Exploratory CTA studies
QTc- prolongation and intensive ECG studies (E14 compliant)
PK studies in renal impaired patients
PK studies in hepatic impaired patients
Special populations studies
Special formulations studies
Vaccine studies
Studies with biotechnology-derived therapeutic products

Large Pool of Healthy Volunteers

PRA is meticulous in our recruitment methods and has access to a pool of over 30,000 active healthy volunteers from The Netherlands, Belgium and the US. We continuously augment this comprehensive subject database through active recruitment strategies. Special populations available from our recruitment database include:

Elderly men and women
Post-menopausal females
Overweight and obese subjects

Well-Defined Patient Populations for Phase I – IIa

In order to provide needed patient populations for Phase I and Phase IIa studies, PRA collaborates closely with local medical communities. We have access to well-defined patient populations from a network of academic and peripheral hospitals.

In our Clinical Pharmacology Center in The Netherlands, our team has experience in respiratory, CNS and metabolic diseases. Through our collaboration with the Amsterdam Medical Center (AMC) and Rotterdam Medical Center (Erasmus) in the Dutch Hepatitis C Initiative, we have expertise in conducting Phase I – IIa HCV patient studies.

Our Central and Eastern European (CEE) operation is entirely dedicated to early phase clinical research in patients. We operate using an innovative business model, applying the concept of 'virtual Phase I units'. In this model, we collaborate closely with local medical communities in Central and Eastern Europe and have access to well-defined patient populations from a network of centralized hospitals. PRA’s patient Phase I and IIa trial experience includes:

Multiple Sclerosis
Parkinson's Disease
Epilepsy
Essential Tremor
Cancer
Cardiovascular
Endocrinological Diseases (diabetes, obesity, thyroid hormone replacement)

Design Flexibility

PRA has significant experience in conducting studies according to many well-accepted study designs including:

single or multi-period
parallel, serial or crossover
open-label
single or double blinded
ambulatory or inpatient
pilot studies
studies utilizing drug run-in phase

In open discussions with our sponsors, we optimize designs in terms of time, resource, data requirements, and clinical environments exclusive to each of our clinics.

Special Equipment

To monitor safety and pharmacodynamics PRA has devices available for:

Continuous (telemetric) cardiac monitoring
ECG
Blood pressure and oxygen saturation measurements
Other pharmacodynamic parameters:
- pupillometry
- ergonometry
- lung function
- gastric pH measurements
- coagulation tests
- urodynamic tests
- imaging techniques such as PET, SPECT and MRI

In-House Pharmacy

Clinical studies of new compounds invariably start at the clinical unit pharmacy. PRA's in-house pharmacies comply with all relevant requirements. We manufacture and dispense all types of formulations such as:

IV, SC or IM infusions and injections
oral solutions, suspensions or emulsions
tablets and capsules
intra-nasal or inhaler techniques
ointments and patches for dermal delivery studies

In our Netherlands in-house GMP-compliant pharmacy, we produce small custom-made batches and match encapsulation for placebos for a specific study. Whether the project involves non-aseptic, aseptic or even radio-labeled preparations, PRA’s pharmacies can accommodate the study requirements. Click here to review an article on the importance of on-site, small-scale GMP manufacturing to early phase development.

Expedited Regulatory Approval

One of the key aspects in clinical studies is regulatory approval. In the US, we offer expedited IRB approval timelines according to the industry’s 8-day approval period standards. Clinical studies can be more rapidly initiated in The Netherlands than in any other EU-member state due to Dutch government regulations for clinical research, which comply with the European Clinical Trials Directive. By law, the Dutch Competent Authority reviews Clinical Trial Applications (CTA) within 14 days. The Independent Ethics Committee (IEC) meets biweekly, making full written regulatory approval obtainable within two weeks.

Reducing Timelines to a Minimum

As an expert in early phase clinical development, PRA understands that short timelines are crucial. We efficiently manage the total early development process and reduce timelines to a minimum by:

Completely integrating activities (clinical research, bioanalysis and statistics)
Integrating internal project teams
Shortening internal communication lines
Rapidly processing data
Closely collaborating with the sponsor

In many cases, PRA can complete the entire Phase I-IIa development program within six months using our dedicated Fast Track development program.