The Lister Group -- Core Services

Clinical Research Services Inc.

Core Services
Effective project management is key to clinical research. Receipt of consistent and accurate study data will result in timely completion of clinical trials. This reduces the time it takes for drugs to be launched in the marketplace. The Lister Group provides critical processes to your company to ensure that your projects are managed properly.

Protocol Management

A properly executed protocol is crucial to the success of all clinical trials. We can provide expertise to physicians and study coordinators that will help them successfully implement protocols at study centers.

Study Monitoring

Physicians and study coordinators require guidance and mentoring in all aspects of project procedures. We will ensure compliance with HPB guidelines and FDA regulations regarding clinical trial material, adequate study record files and completion of case report forms with authentic and accurate data.

Compliance Auditing

Quality assurance is particularly important for credibility of data. It also assures that the conclusions presented are correctly derived from raw data. We have the expertise to verify the processes involved in: subject characteristics, rights and safety of subjects, appropriate consent procedures, adherence to regulations, administration of test article, verification of reported results and "raw data" files.

Physician and Site Selection

We will select qualified investigators and appropriate study sites in accordance with protocol requirements.

Investigator Meeting Planning

We have the experience and expertise to plan and conduct pre-study meetings to teach investigators and study coordinators, protocol-specific procedures for multicenter trials.

Informed Consent Documents

The invitation to a prospective research subject to participate in a clinical trial is crucial. We have the expertise to construct a model consent form and patient information sheet that describes the objectives of the study, and contains the essential elements and information for subject selection.