Outsourcing global clinical
& medical engagement for accelerated drug approval
& acceptance
AnswerY™, an AI-driven, HIPAA-compliant platform of prescriber-patient conversations that drives next-best actions
Outsourcing global clinical
& medical engagement for accelerated drug approval
& acceptance
AnswerY™, an AI-driven, HIPAA-compliant platform of prescriber-patient conversations that drives next-best actions
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Small to mid-sized pharma companies are increasingly launching products, necessitating robust commercial compliance programs to navigate regulations + safeguard profits. The push, often led by general counsel + chief compliance officers, faces challenges like limited resources and expertise in crafting effective compliance strategies.
Why it matters: As these pharma companies expand, the complexity of adhering to both U.S. + international regulations grows. Compliance not only protects against legal risks but also enhances operational efficiency.
The big picture: The U.S. Office of Inspector General (OIG) and international standards like the Organization for Economic Co-operation and Development (OECD)’s Principles require tailored compliance frameworks. If you don’t have the resources, you need a partner to help offer readiness assessments, strategy development + support services.
By the numbers: Preparing for a pharmaceutical product launch involves a 12- to 24-month period of readiness assessment, identifying risks + setting a compliance roadmap based on OIG’s 7 recommended elements.
The bottom line: Effective compliance is crucial for the smooth launch and sustained success of pharma products in the competitive + regulatory complex market.
Below are examples for each of the 7 elements included in the OIG’s Compliance Program Guidance for Pharmaceutical Manufacturers.
| Out-Of-The-Box Example | Business-Aligned Example |
|---|---|
| Drag-and-drop policy templates with irrelevant business practices. | Customized policies designed to enable business success while preventing regulatory risk. |
| Out-Of-The-Box Example | Business-Aligned Example |
|---|---|
| All responsibilities fall to the general counsel or chief compliance officer. | Strategic oversight provided by the chief compliance officer with designated compliance leads(s) + committees to effectively support the different needs of the business. |
Tip: If your company is global or has subsidiaries, consider appointing a country-level compliance officer + country-level compliance committees within each subsidiary. This doesn’t mean you need to hire all different people; you just need the right organization structure.
| Out-Of-The-Box Example | Business-Aligned Example |
|---|---|
| Lengthy, plain-text policy document followed by a “check the box to confirm you’ve read + understood the content and the spirit of the content.”
Typically, these forms are scrolled through quickly, with little to no content absorption or comprehension. Blended (in-person and digital) engaging training + education programs designed to drive a thorough understanding of compliant activities + compliant behaviors relevant to individual roles + company expectations. |
Blended (in-person and digital) engaging training + education programs designed to drive a thorough understanding of compliant activities + compliant behaviors relevant to individual roles + company expectations.
Customized learning management system that hosts processes + procedures for easy, ongoing reference; continuously improves to adapt to the ever-changing industry landscape; and stores reliable documentation of historical records. |
| Out-Of-The-Box Example | Business-Aligned Example |
|---|---|
| Compliance hotline that’s difficult to find; limited human interaction. | Address compliance questions + concerns in real time via readily available resources (e.g., an anonymous reporting system that allows communications with reporters, an ask-me-anything helpline service, a dedicated compliance resource to support the sales team). |
| Out-Of-The-Box Example | Business-Aligned Example |
|---|---|
| Infrequent manual expense report reviews + field ride-alongs (often identifying issues dating back months). | Ongoing risk-based monitoring + auditing with natural language processing + artificial intelligence auditing things like call/interaction records, expense reports + healthcare professional service arrangements like advisory boards to catch + correct before little things become big problems. |
| Out-Of-The-Box Example | Business-Aligned Example |
|---|---|
| Recommendations of well-publicized disciplinary guidelines to use as a reference. | A protocol that is integrated into auditing + monitoring activities and is designed to promptly correct problematic behavior before it could lead to severe consequences for both the employee + the company that involves line management. |
| Out-of-the-Box Example | Business-Aligned Example |
|---|---|
| Templated, vague investigation + corrective action process documentation. | Standardized templates + procedures that involve line management in corrective-action decisions designed to prevent future occurrences. |
In contrast to the out-of-the-box examples, business-aligned standards are obviously better suited for an effective compliance program. Remember, a company’s compliance program is a representation of its commitment to the highest standards of corporate conduct.
Designing a commercial compliance readiness program aligned with the OIG’s guidelines requires time + expertise. If your team doesn’t have the resources to do this internally, an experienced external partner can provide valuable support. Here’s some considerations when selecting a compliance partner:
A well-designed commercial compliance program is not a barrier to profit, but a vital part of achieving sustainable growth. Choose a partner who understands pharma compliance + takes the time to understand your goals.
With expertise in 100+ sales launches, we provide tailored support, from readiness assessments to compliance strategy development, that aligns with the OIG’s recommendations + your unique goals.
To learn how we can help you deliver successful launches, visit Amplity Sales.
