Compliance Solutions for the Life Science Industry
For a Pharmaceutical Company, in anticipation of its CIA, we worked with the Company to identify those processes most at risk (CIA Scorecard Assessment). Having identified those processes with significant gaps, we kicked off numerous projects aimed at addressing the deficiencies and eliminating the Compliance Risk associated.
For a Biotechnology Company, we performed an assessment of the Grants Function and developed a number of business processes and supporting documents to cover the role of the Grants Function as well as the business processes that not only govern its operations but which make it compliant with Agency regulations.
For a Pharmaceutical Company, we performed an assessment of the Publications Processes to confirm the level of compliance. We subsequently develop robust business processes as well as supporting documentation to govern the operations of the Publications Group and ensure it was compliant with Agency Regulations.
For a Pharmaceutical Company, we developed a number of scorm compliant e-learning training modules around HCP engagement, HCP communications, Interactions with Consultants and Corporate Sponsorship.
For a mid-sized Company, DArcy Consulting established business processes for a number of the client’s key clinical processes including Protocol, Informed Consent, CSR as well as Statistical Analysis Plans. We worked closely with the business functions and Compliance groups to develop the supporting documentation (SOPs and Guidance documents).
For a Company which had received a 483, we developed the business processes and supporting documentations to transform the Medical Writing Function – ultimately establishing a process for timely and efficient completion of the Clinical Study Report.
For a Company that had received a Warning Letter, we undertook a complete review of its Biometrics Function (Data Management, Statistics & Statistical Programming). As a result of the Gap analysis, we worked closely with the Group to establish a robust operating model to ensure it became not only Compliant but a high performance group within the Clinical Function.
Over the years our team has helped Companies reduce their compliance risks while increasing overall business performance. While our approach varies, our clients enjoy similar experiences – measurable success. To see what we have done for other Companies, please review the list of Client Projects below.
Please contact us at your convenience for an initial consultation. We look forward to hearing from you.
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For a mid-sized Company which had received a multiple citations, DArcy Consulting led the design and development of multiple processes to support CAPAs generated in response to the findings. These included processes for SUSARS, Informed Consent processes, Protocol Developments. Partnerships with Compliance and Business Functions underpinned a successful engagement.
For a major Pharmaceutical Company, we developed the blueprint for a Clinical Compliance operation model. This covered the overall structure, roles, responsibilities as well as some operating processes (the project was discontinued due to an M&A).
For a Company that had acquired another Organization, we coordinated and supported the transfer of all Policies & Procedures to the Acquiring Company’s Controlled Document system. This included systematically going through all 250+ documents to determine what would be kept, retired, kept for ongoing studies.