Sampling

A strong sample accountability program will address many aspects of business: compliance risks, business risks, ethics, and future program enhancements. Where does a pharmaceutical company start when creating a new or evaluating an existing sampling program? How can you be sure the same principles are being applied to every aspect of your existing program? Are employees adhering to the program with the same principles? How can you approach an audit of your program with these principles in mind? The questions and concerns can seem endless.

Similar areas of compliance and business risks continually overlap in a sampling program and those responsible for a comprehensive and compliant sampling program often feel frustrated when trying to enforce requirements. None the less, it is important to have a program that not only protects an interest in PDMA and 21CFR203 compliance, but establishes corporate protocol and encourages employee accountability. Written policies and procedures must exist to establish and monitor training programs, document corrective and disciplinary actions with regard to employee compliance, manage vendor compliance, control the integrity of documents and forms and provide for successful monitoring of co-promotional agreements. Program gaps or inconsistencies can be difficult for someone within the organization to identify .

CIS’s experts have experience in the pharmaceutical industry as former sales representatives as well as former sample compliance managers. As a result, we know how a sample program should work and the ways adherence is often circumvented. We can identify areas that are often critical to a program, but lacking in controls. We offer solutions for monitoring and corrective action that are unique and often, fool-proof. CIS provides solutions for the pharmaceutical industry that addresses every aspect of a drug sampling program, from implementing a new program to providing a gap analysis and review of existing policies and procedures.