P. Kasper & Associates offers the following services:

Supporting Monitors

This service can be ideal for busy Directors or Managers who want to provide additional guidance, instruction and encouragement to their Monitors. An experienced consultant can accompany a Monitor in the field during a site visit.

A performance plan can be created with the Director and Monitor prior to the monitoring trip. The consultant works side-by-side with the Monitor during the visit to mentor and advise. Finally, a trip summary and performance evaluation can be provided to the Director.

Coaching Site Coordinators

Clinical Research Coordinators find this service helpful as they enter the field or start a new project. An on-site meeting can provide training and support for investigative site staff.

An experienced consultant can give the Clinical Research Coordinator specific tools, clear guidance, and encouragement to recruit patients effectively and complete documentation accurately in compliance with GCP.

Auditing Training Records

Ensure that your departmental training records are in compliance with GCP. This service can review training files and identify any deficiencies. A recommendation for completing the records can be provided. Clinical departments that are preparing for a QA Compliance or FDA audit may find this service useful.

Writing Standard Operating Procedures (SOPs)

This service can help Directors who are starting or expanding clinical research departments for drug or device companies. SOPs that are clear and concise help your staff follow procedures consistently. It is often difficult to find the time to write all the SOPs needed to run a clinical department.

Our experienced professionals can write or revise clinical research SOPs for your department that are effective, complete, and in compliance with GCP.