Clinical Monitoring

A dedicated clinical team of highly skilled and well-trained PPD professionals provides consistent and effective monitoring and interaction with study sites. To ensure seamless communications with your organization, a single project manager serves as your contact for all aspects of your study.

Clinical Research Associates (CRAs)

PPD employs and works to retain top-notch CRAs. While at PPD, they:

Are required to complete successfully a residential U.S. FDA-accredited foundation program
Must demonstrate site monitoring proficiency to PPD management before being allocated to a study
Are typically dedicated to one protocol at a time to maintain quality
In Europe and Asia, are assigned to monitor sites in their home countries, providing understanding of local languages, regulations, customs and business practices

Clinical Conduct

For post-approval studies, PPD will often use a centralized, technology-based monitoring process staffed by our site management group (internal CRAs). All sites receive telephone-based monitoring from PPD’s in-house CRAs, while a limited number of select sites receive targeted on-site monitoring. Customized site management checklists are used, and sites receiving centralized monitoring are provided with a hotline staffed by PPD site management personnel.

During each interim visit, PPD CRAs:

Compare 100 percent of the case report forms (CRFs) to the source documents
Review the CRFs and source documents for serious adverse events
Perform drug accountability
Ensure appropriate signed informed consent forms exist for all study participants
Review investigator study files for completeness
Ensure investigator compliance with the study protocol

Between monitoring visits, CRAs call investigators weekly to verify patient enrollment status, review study progress, answer protocol questions, discuss CRF completion and ensure the study proceeds in a timely manner.

CRAs make final visits to sites to close out studies after all subjects have completed or have been discontinued from the study and after all queries have been resolved.

Clinical Team Management

Involved from site selection through database lock and site closure, clinical team managers oversee and support CRAs by:

Managing the clinical aspects of the study to ensure the collection of clean and quality data
Identifying and resolving potential issues proactively
Keeping projects on time or ahead of schedule
Coordinating site management, site visit schedules, and report preparation and review
Ensuring quality monitoring

Support/Resources

PPD resources that support clinical team managers and their teams include:

Therapeutic specialty groups
Rigorous, ongoing training for project teams in drugs and disease management, good clinical practices (GCP) and detection of questionable data
A Web-based master action plan, project team Web site and online query resolution system to support implementation of every project
Our global clinical trial management system
Ongoing feedback, biannual performance reviews and career progression discussions to develop and retain employees

Site Management Services

PPD works closely with clients to identify investigator sites with a proven record in managing and overseeing clinical studies. Site management includes:

Due diligence to help ensure that each investigator selected is qualified to perform the services required
Collection, review and approval of all required regulatory documents for each participating investigator
Inspection of background information, protocol, study procedures, regulatory requirement, adverse event information, enrollment rates and CRF source documentation