OneSource Regulatory has a passion for helping companies develop and maintain compliance programs. With the right plan, you can integrate business activities and ensure your company is ethical and compliant as it grows. We believe a good compliance strategy and close collaboration with stakeholders is the only way to maintain compliance in our highly regulated industry.
What We Do
OneSource Regulatory helps small companies develop sound ethics and compliance programs. We use the Office of the Inspector General’s seven elements of an effective compliance program as a starting point and then develop programs to meet state and federal compliance requirements so as to avoid unwanted scrutiny, enforcement, and fines. We understand your challenge — we are former compliance officers and professionals. We are here to help your company stay on the right track and out of trouble.
To make that happen, we implement our proprietary four-step process:
- Perform program assessment
Identify and document inherent compliance risks
At this step, we address performance gaps by assessing employees across the board in all departments, from marketing, customer service, and sales to your medical and clinical personnel. We analyze how each of them personally handles interactions, programs, and messaging with healthcare professionals.
Compliance program development
We will provide your company with direction and support to help you implement a compliance program that adheres to the Office of the Inspector General’s guidance.
Compliance monitoring and support
OneSource Regulatory will provide ongoing and/or periodic support for your company’s compliance programs and operations. We can monitor how marketing campaigns or corporate initiatives in the field are implemented, as well as how contracted healthcare professionals are managing the delivery of speaker programs and other medical education content. An effective compliance monitoring program will diagnose compliance failings quickly, providing an opportunity to develop solutions and improved compliance over time.
OSR has worked with over 40 companies to provide:
- Compliance expertise and guidance
- Customizable compliance policy templates and defined processes
- A resource library of materials and tools
- Access to OSR’s compliance training platform
Monitoring and Auditing
The compliance monitoring program OneSource Regulatory provides includes:
- Field monitoring of ride alongs and speaker programs
- Monitoring of data analytics from sales representatives, doctor interactions, and email
- Strategic monitoring plans such as quick start guides and plans for protocol development
Let OSR help you design a cost-effective monitoring program that leverages:
- Digital monitoring technology
- Records and transaction monitoring
- Focused area monitoring (e.g. field representative ride-alongs, live speaker programs, congresses and medical affairs activities)
We welcome the opportunity to learn more about your current and ongoing needs and we strive to adapt our services to your objectives. We offer the following support models:
- Flexible staffing resources to augment your team, from officers to compliance staff
- Training programs to bring your company up to speed quickly
- Full monitoring, auditing, and investigative services
- Outsourced compliance functions