Phase I

Neozene specializes in providing clinical study expertise for the management of your Phase I trials. Whether your Phase I type is first time in human, a dose tolerance study, a food effect study, a Pharmacokinetic (PK) study or a Pharmacodynamic (PD) study, our experienced staff can work with you to ensure:

• The Phase I center and personnel are trained on conducting the trial.
• The appropriate regulatory documentation is collected and maintained.
• Clinical data are being collected using Good Clinical Practices.
• Adherence to study protocol.
• Safety data are being collected and reported to regulatory agencies.

Through our extensive Phase I experience, we have found that PK trials demand an additional level of expertise because of their uniqueness and complexity. In addition to the standard activities performed on other phase I studies (such as verifying informed consent, protocol compliance, AE reporting, and investigational product handling), PK studies also require:

Verification Of Drug Administration

Study drug administration is monitored for compliance. Dosing for PK studies is critical to the success of the Phase I trial as it sets the stage for all events that occur in the specified period of the study. An error in the administration of the drug can cause issues in the accuracy of the sample collection so great care must be taken with study drug administration.

Accurate Sample Collection

Sample collection and handling procedures must be in place and must be followed to ensure the timely collection of samples for PK analysis. Capturing of samples for PK analysis is critical to finding the representative PK sampling concentrations and comparing to other results.

Verification Of Sample Shipment

We will help you ensure that the medical record, sample, and study documentation match each sample that is collected, processed, and shipped for analysis. An error in this processing can cause a lot of issues in data analysis. Neozene’s monitoring services guarantee your Phase I study is compliant with protocol and local regulations. To facilitate these services in a timely and cost-effective manner, our monitoring staff is located throughout the country near many of the major Phase I facilities. This regionalized model—along with our monitors diverse experience with multiple client networks and systems—enables Neozene to quickly respond and provide results to our client needs.

We also customize our service offering to our clients’ study specifications in order to increase efficiency and productivity. A project manager, who will become an extension of your internal team, directs the Neozene study team. This makes the communications link direct, concise, and effective.