CLINICAL COORDINATING CENTER

COORDINATION FOR YOUR CLINICAL TRIALS

PSC Clinical offers a wide range of services from which study sponsors can select according to the needs of their specific clinical trials.

Protocol implementation monitoring and review

PSC Clinical provides review and on site monitoring of trial protocols by experienced Quality Assurance personnel to verify that the clinical sites meet protocol requirements, staff is properly trained as per protocol, and all guidelines and regulations are being correctly followed. Our QA staff will provide reports detailing protocol discrepancies and procedure deviations, as well as suggestions on the measures that need to be taken to remedy such issues.

Research staff training

PSC Clinical staff will share their wealth of experience by helping in the development of training and orientation media for clinical trial staff. We will also coordinate with the proper parties to create a computerized training record database and enter all training records of personnel involved in the trial into the database.  

Testing and analytical laboratory management

PSC Clinical can manage on site testing including: drug testing, pregnancy testing, disease screening testing, and alcohol testing. We will ensure that all relevant registrations and licenses are acquired and that proper documentation is provided on site. We will provide liaison with a suitable local analysis laboratory and set up a shipping system to ensure timely delivery of samples. We will procure all necessary testing materials in sufficient quantity. All testing and related procedures will be thoroughly documented in a secure fashion.

Protocol development

Proper protocol development is a critical step for a successful project. PSC Clinical personnel are highly experienced in the development of protocol documents and we are happy to assist in the production of documents such as training, quality assurance, management, and data compilation plans, as well as any report or investigational templates required for the trial.

General support services

Because of the unique nature of many clinical trials, unprecedented services are often required. At PSC Clinical we make it our goal to conform to the needs and requirements of our sponsors, and strive to be flexible in the services we provide. To this end, we will be happy to provide PSC Clinical staff involvement and expertise in any capacity needed by the trial sponsor.

Regulatory functions and requirements compliance

Clinical trials are heavily regulated by agencies such as the FDA, and compliance with these regulations is critically important. PSC Clinical is dedicated to ensuring that its clients conform to the regulations and requirements pertaining to their particular trial and provides review and verification of areas such as: training requirements, trial participant consent and compliance, and trial protocol. We will also verify or generate all necessary documentation for adherence to all relevant regulations and requirements.