Program Strategy, Design, and Development

Dovetail consultants have extensive experience working with life sciences companies, in all stages of maturity, to assess, design, and implement ethics and compliance, privacy and data protection programs and their respective components. Having built these programs ourselves in-house, we understand the importance and nuances of dialogue with key stakeholders and of building internal support for programmatic changes.

For companies in the earlier stages of commercial readiness or compliance maturity, we work with executives and managers to create and implement solutions that are the right size and take a balanced approach to meet current business needs and scalable to address future growth. We help companies think through:

• The organizational design of the function
• Strategic plan development for board, budget, and annual workplan discussions
• Various governance models and effective allocation of risk ownership
• The elements of an effective program, assessing risks and gaps
• Globalization strategies, including expansion into new markets and scaling existing structures and roles
• Cross-functional linkages and efficient implementation strategies

Policy and Process Development

With thoughtful governance and control documents in place upstream, companies can mitigate risk and limit the need for distracting downstream investigations and enforcement. Dovetail has deep content and operational expertise that enables us to write, review, and periodically update policy and procedure documents that help our clients comply intelligently with applicable rules and regulations. We also help think through policy library and learning management solutions to ensure that your program is on the leading edge of a constantly evolving industry.

Privacy and Data Protection Management Solutions

Meeting business and growth objectives and maintaining functional operations requires sustained access to personal information of customers, consumers, patients, partners, employees and other stakeholders.  The evolving privacy and data protection landscape presents increasingly complex challenges for the life sciences industry, impacting nearly every aspect of an organization’s business—from clinical studies and market research to commercial operations, Patient Support Programs and human resources.

With extensive experience in global Privacy Management Program design and implementation, Dovetail Privacy experts assist companies in developing scalable solutions aligned with business strategy, company culture and compliance objectives.

Whether an organization’s Privacy Management approach is executed as part of an independent function or is part of the Compliance or other risk management strategy, Dovetail provides unique insights and recommendations to drive holistic and cross-functional privacy risk management efforts, increase process efficiencies and empower organizations to build and foster a culture of responsible data stewardship.

Patient Support Program Compliance Services

Dovetail develops proactive compliance frameworks to drive successful PSPs while mitigating risk. Our compliance professionals will advise you on how to execute your charitable giving – an area of focused enforcement scrutiny – how employees can interact with local patient association chapters and patient organizations, and how to manage privacy requirements and mitigate risk to patient and caregiver information. 

Whether PSPs are conducted in-house, through hub services, by specialty pharmacies, or by other vendors, Dovetail will help ensure that your PSP’s compliance is successful by helping you design a proactive, right-sized framework to address compliance and privacy risks.  We work with your compliance professionals to ensure they understand the risk areas, and that you have in place effective and efficient controls – such as risk assessments, monitoring techniques, or policies.

In its work with you, Dovetail will not only focus on external patient and stakeholder touchpoints, but also on how internal personnel cooperate and interact with one other, process design and efficiencies and cross-functional alignment.

Corporate Integrity Agreement, Consent Decree, Work Plan, and Deferred Prosecution Agreement Assistance

Dovetail experts have assessed, negotiated, and implemented enforcement mechanisms. We understand that satisfying the demands of a government investigation can distract and exhaust the resources of lean compliance departments. We offer support for pre-CIA readiness assessment, work plan and Risk Assessment Management Plan (RAMP) development, vendor evaluation, and remediation efforts compliant with the requirements of the government. Additionally, Dovetail has government IRO and board-expert experience. We help our clients communicate effectively both with directors and with the government to ensure that the company's needs are understood by all involved parties.