Phase I Study Services.

Since the mid 1980’s PHAROS GmbH and our core staff have a proven track record in research as well as in development and performance of the most demanding and often the most innovative study designs.

As a team we have designed, supervised and completed more than 1,000 Phase I and Phase II Clinical Trials which have been used for regulatory submissions world-wide.

Each PHAROS GmbH Project Manager has successfully managed and coordinated complex development projects for at least 7 years.

We are specialists in solving problems that have defied conventional solutions, using our expertise and the scientific knowledge available to us to develop alternative strategies and study designs. Our recommendations to you are based on your needs and are independent of our ability to ultimately perform the clinical trial we suggested.

With the PHAROS GmbH System, Phase I and early Phase II Clinical Research can be redefined to give you more information than thought possible before.

In our own Clinical Pharmacology Unit we perform these Types of Clinical Trials:

• First Administration to Man.

• Safety and Tolerability (Systemic, Local, Topical).

• Intensive Monitoring.

• Single Dose, Single Rising Dose, Multiple Dose, Multiple Rising Dose.

• Pharmacokinetics and Pharmacodynamics.

• Absolute and Relative Bioavailability.

• Pharmacokinetic Interaction (Drug-Drug and Drug-Food).

• Pharmacodynamic Interaction.

• Pharmacodynamic/Pharmacokinetic Modelling in Healthy Volunteers or Patients.

• Identification and Validation of Surrogate Markers of Drug Activity.

• Pharmacokinetics in Specific Populations (Gender, Age, Specific Disease States).

• Pharmacokinetics in Organ Impaired Patients.

Your personal benefits:

• Complex studies can be set up and completed swiftly and smoothly due to our creative potential in study design and our vast experience in clinical trial performance.

• Our ISO9001 certified Quality Management System ensures data security and regulatory compliance of all projects.

• Single PHAROS GmbH Project Manager, remaining your constant partner throughout the complete project duration.

• Fair and transparent costs through custom-tailored contracting-in

For details about our Clinical Trial planning and performance check our
Clinical Trial Elements and Procedures