Policies & Procedures
We work with clients to author and implement compliance documentation.
What differentiates us is our ability to recognize the complex challenges facing life science organizations and develop clear, structured compliance documentation. As experts in the compliance space, we are used to working with Compliance and Legal counsel to understand the minutiae of policy decisions. And with deep practical experience, we understand the impact these decisions have on business processes.
We view compliance documentation as a pyramid starting with the Code of Conduct and culminating with informal, uncontrolled documents. See image below.
Each layer, with its increasing level of detail, is critical to meeting government requirements. Potomac works with clients to create compliance documentation in an organized, easy to read format. Our policies and procedures have consistently met the standards of Independent Review Organizations tasked with confirming the requirements of our clients operating under Corporate Integrity Agreements.
However broad or specific your need, our experienced professionals can help you to create compliance documentation to reach your specific audience. We bring experience on a wide range of compliance topics from commercial and medical interactions, patient interactions, and clinical trials, to funding and support of external organizations.
Click here or on the image above to access our Developing Written Documentation infographic with information on OIG documentation guidance and CIA requirements as well as Potomac’s recommended documentation framework and development process.
Click here to access our Policies & Procedures brochure and learn more about our services.
Launch Pad policies are the perfect starting point for companies looking to rapidly build out a compliance program in advance of their first drug approval or as a supplement to an existing compliance program.
These documents include individual policies and functional-specific policy manuals that are drafted and ready to go. The existing templates allow us to easily customize areas to fit your company’s needs, such as company-specific processes, criteria, and department or division names.
Potomac has existing Launch Pad policies covering more than two dozen topics including the following:
- Contracts with Healthcare Professionals
- Communications with HCPs
- Speaker Programs and Speaker Training
- Meals and Venues
- Educational Items
- Advisory Boards
- Conventions, Exhibits, and Display
- Promotional and Non-Promotional Material
- Clinical Trials and Publications
- Investigator Initiated Studies
- Educational Grants and Charitable Contributions
- Medical Inquiries
- Samples, Coupons, and Vouchers
- Interactions with Patient and Patient Organizations
- Managed Care and Reimbursement
- Conflicts of Interest
- Social Media
- Compliance Office Infrastructure
- Transparency Reporting Requirements
We also have prepared Launch Pad Manuals for Field Sales professionals, Medical Science Liaisons, Field Reimbursement professionals, and Headquarters staff.
Expert Content with Professional Design
Together, our consultants and graphic designer develop tailored documentation to communicate essential information. We are experts at simplifying complex content and providing businesses with relatable, meaningful solutions. Our Design Specialist is proficient at using visual cues, messaging hierarchy, and informational graphics, for example, to help bring compliance documents to life.
All of our custom documentation reflects each company’s culture, content, and design standards. Our team has experience developing such customized documents as:
- Codes of Conduct
- Policy highlights
- Field Manuals
- Quick reference cards
- Checklists and forms
- Protocol and process guides
- Visual identities