Phase I clinical trials are the first studies of a new drug in humans. These studies provide a preliminary evaluation of drug safety, tolerance and pharmacokinetics. The metabolism and pharmacologic actions of the drug are determined, as well as the side effects associated with increasing doses. If possible, early evidence of effects is gained. Phase I studies are typically closely monitored and may be conducted in patients or healthy volunteers. At this stage, companies are striving to obtain a reliable profile of human safety and an early indication of efficacy in order to maximize their revenue potential.
The primary goal of our Phase I Clinical Research Units (CRUs) is to provide comprehensive Phase I clinical and data services, including bioanalytical and pharmacokinetic support to targeted markets. Key academic affiliations allow for unique innovative clinical studies to establish safety as well as pharmacological endpoints to achieve proof of concept earlier in drug development. In addition, CCDRDs Strategic Product Development team works closely with the Clinical Research Unit to integrate the nonclinical and early clinical development needs into a cohesive early development plan to reach go/no go decisions efficiently and rapidly.
CCDRD works with Phase I units embedded in academic hospitals that draw from an extensive database of volunteers in Germany, France, Poland, the Czech Republic, Bulgaria, and Turkey. Our units are audited by EU authorities and a number of leading multinational pharmaceutical companies. The location allows to fulfill the need of generic development in most of the cases. CCDRD works routinely with several Phase I units throughout Europe. An overview of capacities is given below.
The units in Germany, France, and the Czech Republic offer the possibility for continuous monitoring of vital signs. When needed, more intensive cardiovascular monitoring can be performed in these units. All units are experienced in performing bioavailability/bioequivalence trials and the SOPs followed in all units are identical. The time needed to receive regulatory approval for a trial varies from 2-4 weeks to 8-10 weeks.
| Country |
Number of Volunteers |
| Germany |
34 |
| Poland |
8 |
| Czech Republic |
12 |
| Bulgaria |
34 |
| Turkey |
48 |
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Please note that the capacities given above are for simultaneous conduct. Larger trials are easily accomplished by interleaving trial periods and just take 1-3 weeks longer. The early development process is composed of choices that explore the viability of bringing new drugs to market, and CCDRD specialists have a successful 20 year background to manage the transition from nonclinical to Phase I development successfully. Phase I studies provide a preliminary evaluation of drug safety, tolerance, and pharmacokinetics, including in vitro/in vivo correlations and phK/phD relations. CCDRDs Phase I Clinical Research Units provide both traditional and specialty Phase I capabilities to both pharmaceutical and biopharmaceutical companies, as well as non-drug-related companies. For generic development we can offer experienced and agency approved/audited phase I units in off-patent areas. We have conducted numerous phase II studies with different routes of administration. The key to success lies in the proper choice of the trial endpoint with regard to the administration route.
Studies conducted at CCDRD AG included following routes of administration. - Oral
- Buccal
- Nasal
- Rectal
- Vaginal
- Pulmonary
- Topical
- Transdermal
- Ocular
- Intravenous
- Subcutaneous
- Intramuscular
- Intravenous
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