Pharmacology trials
(PK and PD, BA and BE,
Drug-drug and Food-drug interaction)

CRS is well experienced with quite different kind of clinical trials

CRS stands for highest quality study services and trial performance, but also fast turnaround times

Every investigational product has to pass an elaborate and complex trial program before being placed on the market as a new medication. In this respect a clinical trial is a procedure that is designed to test a specific investigational product for therapeutic action features, for efficacy, tolerability and safety, as well as for pharmacokinetic (PK) and pharmacodynamic (PD) properties.

CRS is well experienced with quite different kind of clinical pharmacology trials such as:

• First-in-Human (FIH) clinical trials (single and multiple dose)
• Pharmacokinetic (PK) and pharmacodynamic (PD) studies
• Bioequivalence (BE) and bioavailability (BA) studies
• Clinical trials in specific population (e.g., renal impairment, hepatic impairment, age, gender)
• Thorough QT/QTc (TQT) studies
• Drug-drug interaction studies
• Food-drug interaction studies
• etc.

CRS conducts clinical pharmacology trials, PK and PD studies included, regardless of the route by which the investigational product must be administered, whether oral, intravenous (IV), subcutaneous (SC), intramuscular (IM), or otherwise.

Clearly, the conduct of clinical trials is strictly regulated to ensure that they follow highest ethical standards and comply with international recognized rules and requirements. We at CRS meet the highest requirements of the competent authorities and – this is our commitment – the highest demands of our customers.

Our well-trained and highly motivated staff, working with the best and most up-to-date technology, not only provides you the highest quality of study services and trial performance, but also fast turnaround times.

In this spirit, CRS has accomplished numerous of clinical pharmacological trials over the past 40 years. CRS’s clinical research teams are able to handle large-scale trials with high sample sizes of N = 200 or more; moreover, CRS’s resources guarantee the quickest possible trial performance.

Why conducting PK/PD studies in very early stages of clinical drug development

The inclusion of PK/PD studies in the very early stages of clinical drug development can significantly accelerate the selection of the most promising compounds.

The arguments for conducting PK/PD studies in very early stages of clinical drug development are as follows:

• It provides a quantitative analysis of the dose-response relationships in humans.

• It provides insight into the time course effects of one or multiple doses of the tested drug.

• It is essential for understanding the frequency and the extent of target modulation to observe statistically significant efficacy in humans.

• It determines efficacious dosing (dose finding studies) to define the appropriate dose to be used in Phase II/III clinical trials.

For your best: allow CRS a close look at your trial design

The design of a study is one of the factors that determine the success of a drug development program. However, a poor trial design cannot be easily corrected in the course of the study, but it can disrupt the development program.

This also applies to clinical pharmacology trials, e.g., trials for PK/PD analysis.

Our experts at CRS are often able to suggest changes to the planned clinical pharmacology trail; changes that focus on the results needed and save our clients money.

With CRS, your clinical trial is in best hands

All CRS-owned clinical trial units have the staff, the equipment and the expertise to conduct the trial faithfully according to the study protocol and in compliance with Good Clinical Practice (GCP) and all other regulatory requirements.

This is proven: In 2008, 2009, 2010, 2011 and 2014, the U.S. Food and Drug Administration (FDA) has performed inspections of CRS’ bioequivalence studies and awarded the highest rating in all cases: “No Action Indicated”.

And that’s not all: CRS maintains its own powerful database of healthy subjects and patients as voluntary trial participants. This database together with a solid network of collaborating medical specialists and general practitioners in private practice are key to our highly effective recruitment of healthy subjects or patients with various diseases.

Together with carefully selected external clinical centers of excellence we at CRS can provide a wide range of studies bridging from preclinical evidence to the proof of concept.

CRS’ experienced scientists, statisticians and medical writers can provide essential support in creating powerful study outlines or writing the study protocols in preparation of a study, as well as in finalizing study reports and drafting manuscripts for publication in scientific journals after completion of the clinical trial.

A large number of scientific papers published in international peer-reviewed journals are proof of our outstanding expertise in this therapeutic area.

Now let us get together to discuss in detail how we can move your project forward and save you time and money.

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