Have the answers ready before you face a TMF audit or inspection
TMF practices have matured considerably, and are now recognized as a critical step in the drug development cycle. However, a number of challenges persist. One key issue facing the entire life sciences industry is the fact that sponsors, CROs and affiliates often maintain multiple TMF instances — which increases the manual work required and creates redundant practices and processes that increase the complexity of TMF management.
Other challenges that the Life Sciences industry faces today include:
- CRO coordination, to ensure the right documents are available during audits and inspections.In many cases, CROs manage their TMF system and sponsors manage their own. This makes it difficult to ensure the accuracy, completeness and timeliness of documents, as there is no clear ownership or accountability of TMF documents.
- Governance, for better sponsor oversight and governance of CROs, affiliates and other functional service providers for TMF management. Document submission timeline is also an issue, as documents are often pushed on to the TMF system at the time of inspection, and not on a regular basis
- Quality by Design, TMF operations for many life sciences organizations are combined with clinical trials and regulatory document management functions. This leads to quality issues, because there is not an exclusive focus on TMF documentation, which needs a more thorough and focused approach.
Is your organization facing any of these challenges? Do you need help providing answers in advance of an audit or inspection? If so, we want to hear from you, learn about your challenges, and explore how we can work together to ensure that your organization is always audit and inspection ready.
To start the conversation, reply or comment below, or reach out to us at LifeSciences@syntelinc.com
Rahul Ganar, Senior Business Analyst, Life Sciences, Syntel has more than 10 years of domain and IT experience in strategic solutions, business innovation support, product and solution development, and business analysis for the life sciences value chain. He has experience in managing creative, technical and cross-functional teams which resulted many innovative solutions, tools and frameworks in clinical research and commercial areas.