Our experience includes the following projects. Please note, this list is not exhaustive. Should you require further information about any of these case studies or require a reference site for our work, please do not hesitate to contact us.
Assessment of clinical document processes and systems
The client was at risk of an impending GCP regulatory inspection but were aware that their systems and processes for maintaining clinical trial documentation – the trial master file or TMF – were not optimal. We conducted a review of the SOPs, policies, practices and systems currently being used to manage TMF records in house and also those being used by various third parties that the client interacted with. The review revealed a range of issues that needed to be addressed including overall governance in place for TMF-related issues, the technologies being used to access TMF content on a day-to-day basis and the level of compliance with various regulatory requirements. We developed an action plan for the client which included some quick-wins that could be implemented in a relatively short timescales and at minimal cost, through to some long-term, strategic solutions for them to consider. The client went on to procure a commercial eTMF solution – a process that we also contributed to in order to ensure they chose the best solution to meet their needs.
Development of a records retention policy
The client – a small UK-based pharmaceutical company – required us to produce in very short timescales a records retention policy for the whole company. In addition, we also developed a comprehensive records retention schedule using a process-based approach. The schedule covered all areas of drug discovery, development and business administration, including corporate governance. The work was completed in 11 man-days and was implemented within 3 months of project start.
Development of file plans
The client – a finance-related department within Central Government – was in the implementation phase of a major Electronic Document Management System in order to comply with the e-Government requirements. Rammell Consulting were employed to develop function-based file plans for the whole organization. These file plans were then used to assist in reorganizing legacy records on distributed project drives before importing them into the new EDMS.
The client – a major multinational pharmaceutical company – had outsourced a project to identify improvements to the clinical trial process. Specifically, it sought to improve the way data and documents were managed. Rammell Consulting were contracted to provide expert regulatory guidance to the project team with respect to records management requirements. This included a review and assessment of worldwide external requirements as well as a review of internal company requirements. All applicable requirements were presented in database format to accompany a written report which included recommended actions for the project team.
Records management strategy planning
Following a series of re-organizations, the client – a major multinational pharmaceutical company – wanted to bring together the various records management functions across the company for a 2-day workshop to prepare a five-year strategic framework for records management. In consultation with the global records management champion, Rammell Consulting designed the workshop and facilitated the meeting. This allowed the workshop chairman to act independently from internal politics and any personal agendas or history that may have been present. It also allowed all attendees to participate fully in the workshop.
Rammell Consulting assisted a multinational pharmaceutical company with the development of improved records management and filing processes when interacting with contract research organizations. Historically, processes were either not discussed or were agreed in an ad hoc manner, often with no involvement of records management professionals. Rammell Consulting developed a series of proposals for the client for process improvement which would result in better, consistent practices being followed when working with CROs.
Records management audit/review
We were asked by a biotechnology R&D company to conduct a records audit of their organisation. The audit included a detailed inspection of their clinical trial master files in readiness for an expected MHRA inspection. In addition, a comprehensive audit was conducted of the records management infrastructure within the company. This included aspects such as availability of retention schedules, records policies and procedures (SOPs), a vital records programme and monitoring and auditing procedures. Rammell Consulting then assisted the client to implement the recommended corrective actions.
Records retention requirements
The client was involved in an established project to rationalise its records and data repositories, thereby reducing their IT cost overheads. As a key part of this project, Rammell Consulting were asked to review all applicable worldwide regulations that pertained to records and data in those repositories. We were asked to make records retention recommendations that would enable the records and data to be managed more cost effectively, yet remaining compliant with applicable regulatory obligations.
Use of off-site commercial storage vendors
It is becoming much more common to see companies storing their vital business records with commercial storage companies rather than housing these in on-site facilities. It is essential however to ensure that these facilities meet applicable requirements and just as important, that the contracts and service level agreements include the necessary clauses to maintain continued compliance withh all pertinent regulations. Rammell Consulting has reviewed existing storage contracts for a client, recommending amendments to the text to ensure compliance with industry best practice and with relevant UK Statutory Instruments. We also worked with another client to select a new storage provider, creating a short-list, conducting pre-selection audits of three potential vendors and developing a robust contract with the chosen storage company.