Phlexglobal Case Studies
Case Study:
TMF Quality Control
Key Features:
Provision of an experienced team • Management of services • Meeting a business critical need
Client Scenario:
Phlexglobal was contacted by a Client to quality control TMF site files involving all the European sites of a global oncology study. The sponsor had audited the US site files and identified several significant findings.The sponsor was due to audit the European site files with the expectation that the client company would have the files inspection ready without the significant findings identified in the previousUSaudits. The client company contacted Phlexglobal to assist them in the TMF QC. This project was business critical to the client, it was essential to have the files inspection ready and QC’d to a high quality within agreed timelines and budget.
Phlexglobal Solution:
Phlexglobal worked with the client to ensure a full understanding of their requirements and also recognised the business critical nature of this project. An effective team was created, drawing upon the full range of expertise available within our clinical Task Force, enabling us to include team members with skills specifically matching the client’s requirements.
The team consisted of a Senior QA consultant, who acted as Project Lead, and Senior CRA’s and CTA’s who worked to a high standard to ensure project delivery. The Project Lead coordinated daily activities for the team and was able to provide frequent updates to the client on the progress of the project to ensure they were kept informed of timelines at all times. Project oversight was provided by the Client Project Liaison Manager who kept the Client informed of timelines and budget expenditure on a regular basis and supported the Client through the provision of additional trained staff to address other aspects of their audit preparations.
The TMF QC was completed within agreed timeline and budget and in accordance with client specifications. The feedback from the Client was very positive as they continued to prepare for their forthcoming sponsor audit.
Case Study:
Paper TMF Preparation for Audit and Inspection
Key Features:
Inspection Readiness • Provision of experienced team • TMF Remediation • Quality Control
Client Scenario:
Our Client, a large biotech organization, was facing the challenge of having an incomplete paper TMF. The Client knew that an inspection was imminent and needed to find a resolution for identifying the gaps in documentation from a presence perspective along with the contents of selected TMF documents. Remediation was also required to identify the missing documents and produce a complete inspection-ready TMF.
Phlexglobal Solution:
Phlexglobal started by assembling QC checklists based on the Client’s TMF structure. For this type of project it is essential to get the checklist right, and this particular Client required key essential documents to be content QC’d along with a list of additional documents.
The Client shipped all TMF documents to the relevant Phlexglobal office, whether UK or US. A dedicated team at each location trained in the client-specific QC checklists performed an inventory of the TMF to identify missing or incomplete documents. All results were recorded on a tracker that was regularly shared with the Client. The trends that were identified aided proactive corrective actions for the Client for additional studies. This minimized the time required for remediation activities and allowed for the successful preparation for the TMF inspection within budget and agreed timelines.
Case Study:
Provision of NHS Governance Assistance
Key Features:
Dynamic Team • Flexible Resource • Bridging the gap
Client Scenario:
Phlexglobal was contacted by a National Health Service (NHS) Client, a large comprehensive research network, to assist them in maintaining their provision of NHS infrastructure for clinical research and research management.
Phlexglobal Solution:
The Phlexglobal team was able to work closely with the Comprehensive Local Research Network Research Management & Governance team, assisting with a coordinated system for gaining NHS permissions governance review processes for portfolio studies undertaken by the Client.
The team proved they are adaptable and dynamic, enabling them to work to Client-specific requirements surrounding many of the research management processes such as site-specific assessments, assessment of study applications as well as cost and service support requirements.
The Phlexglobal team was also required to communicate clearly and sensitively to researchers to advise them of any changes during the application review process or additional information required in order to meet Department of Health, regulatory body and legislative compliance.
The roving Phlexglobal Task Force team was able to spend time at the Client’s multiple sites and also work remotely using secure IT links from the Phlexglobal offices offering a cost effective solution to Client requirements whilst maintaining the ability to work at an optimum level.
Staff attrition and budgetary restrictions prevented the client from employing new permanent staff; Phlexglobal was able to bridge this gap by providing skilled temporary staff which enabled the Client to maintain an optimum level of service delivery.
Case Study:
Review of Promotional Material
Key Features:
Provision of experienced team • Management of services • Flexible provision of resource • Transactional Outsourcing model
Client Scenario:
Historically, our Client’s individual offices produced, reviewed and approved all promotional material using their own electronic system. Since 2009, they centralised the production and review of promotional material for the EMEAC region, and were looking to outsource part of this process on an ongoing basis using a Transactional Outsourcing model, where the only cost is the provided item of work.
Phlexglobal Solution:
Phlexglobal provided a team of Clinical Support Specialists. Phlexglobal are responsible for the overall management of the services, including ensuring that the work is performed by appropriately qualified staff within the contractually agreed time frame. This service has been provided to our client on an ongoing basis since September 2009.
All promotional material produced by our Client’s marketing groups is uploaded by them into their electronic system. The Phlexglobal team performs a three-stage review incorporating a Coordinator step to ensure that all relevant documents and basic information are present in the application, a Product Specialist step to perform a detailed review of the scientific claims in the piece against the published papers used as references, along with an editorial check of the piece, and finally an after-the-fact review, to ensure that any changes requested in the first two stages have been implemented. The Client is charged based on a price per job for each stage of the review.
This support service provided our Client with the additional resource required to process fluctuating volumes of promotional material; the flexible provision of resource ensures that periods of high volume are managed and periods of low volume do not incur any unnecessary costs to our Client. The Transactional Outsourcing model has allowed our Client to obtain this additional support within constraints from their own management regarding limits on hiring in contractors based on time and materials. The service also provides our Client with a steady, trained team to ensure a consistent review across all promotional pieces.
Case Study:
Delivery of a complete records management solution including implementation of a global eTMF for a top 25 global pharmaceutical company
Key Features:
Implementation of global eTMF system • Over 100 studies & 1.7 million documents loaded into PhlexEview • Over 600 global PhlexEview users • Remapping of CRO to client filing structures
Client Scenario:
Our Client, a European affiliate of a global pharmaceutical company, required a solution to resolve their problems with a lack of compliant TMF storage, decentralised documents, lack of in-house resource, lack of quality control before archive and the need to incorporate CRO documentation. The longer term vision was to implement a global eTMF that would support international alignment and, through file reviews, audits and Regulatory Inspections.
Phlexglobal Solution:
Following a period of in-house consultancy in 2006, Phlexglobal implemented PhlexEview as an eTMF solution to the Client’s problems. A phased approach was adopted to ensure that PhlexEview, as a system and best practice processes, offered the solution to our Client’s problems. Planning and design included understanding user requirements, assessing initially 65 global studies and User Acceptance Testing (UAT) of a pilot study. Process mapping and re-engineering looked at workflow requirements and TMF restructure, streamlining of current process and secure storage, CRO partnerships and effective processing of over 250,000 retrospective documents into PhlexEview.
Since 2007, PhlexEview was rolled out to our Client’s CROs and documents were received from disparate global locations across a number of studies. PhlexEview was used to facilitate a number of audits and file reviews and also provided our Client with documents to assist with writing clinical study reports and an eCTD submission.
Over 4 years after the successful implementation of PhlexEview, our Client utilises PhlexEview in a truly global manner by employing the same approach in the US.
Through effective global project and operational management, our Client and Phlexglobal maintain a close partnership which ensures customisable PhlexEview development and continual improvement to meet Client needs.
Case Study:
The implementation and ongoing management of a global eTMF for a top 30 global pharmaceutical company
Key Features:
Implementation of a global eTMF system • Incorporating 3 disparate filing structures • £12m over 5 years • Pilot using a Phase I study • 200 users accessing PhlexEview
Client Scenario:
UCB, a newly merged global pharmaceutical organisation, was facing the challenges of integrating legacy and disparate trial management systems and filing structures, whilst maintaining ‘business as usual’. UCB was looking for an appropriate outsourcing model which would result in a new global eTMF enabling office based or remote access by internal and contract staff. Anticipated to continue over 5 years, the project will include ongoing management of both the paper and electronic TMF documents.
Phlexglobal Solution:
Following an initial pilot period using a completed Phase I study, the global roll-out of the eTMF was performed according to a controlled and phased plan. By January 2010 all three of UCB’s filing structures had been implemented (2 legacy and 1 current) in PhlexEview, Phlexglobal’s end-to-end eTMF, and in excess of 200 users had access to the system.
Trial master file documentation is now categorised according to ‘backlog’ or ‘ongoing’ criteria before being processed – a procedure involving the scanning, indexing and QC of documents according to predefined conventions – within contractually agreed timeframes.
In addition to the usual expected benefits of centralised eTMF documentation, the eTMF has enabled the delivery of significant other advantages. Perhaps most beneficial is the management oversight PhlexEview provides, giving key UCB users complete overview of which study documents are present, or more importantly missing, at any one point in time. This feature is invaluable when preparing for any regulatory inspection. Document throughput and CRO contribution can be carefully reviewed allowing for earlier intervention where required.
Throughout the planning, design and implementation phases of this project, UCB and Phlexglobal have worked in close partnership, allowing for the development of a bespoke solution which continues to meet all of UCB’s goals and objectives.