TMF Launchpad
The accelerator program for start-ups and CROs to effectively fast-track clinical trials.
The Challenge: Trial Master Files
Trial Master File (TMF) management is a complex process that requires accurate documentation and compliance with regulatory requirements, often leading to errors and delays when not managed appropriately. Manual handling, poor collaboration and a lack of traceable changes further complicates efficient study management.
Docuply offers an automated TMF management solution that streamlines the entire process, ensuring it is error-free. By natively integrating the CDISC TMF reference model into our solution, we sre able to facilitate audits. As part of the TMF Launchpad program, Docuply provides its platform free-of-charge to accelerate clinical trials from their inception, minimizing administrative burden.
Successful clinical trials start with reliable partners. Benefit now from the advantages of the TMF Launchpad.
What does the
TMF Launchpad program offer?
- 1-year access to Docuply for up to 10 users, free-of-charge
- Unlimited document management for studies and sites
- Compliance with regulatory requirements
- Support of the CDISC TMF reference model
- Pre-validated system including ongoing documentation of installation and operational qualification (IQ/OQ)
- Dedicated ongoing support from our experienced support team
- Template package: SOPs, checklists and other templates
- 1:1 mentoring with one of our Quality Management (QM) and clinical experts
Who is this aimed at?
- Biotech and pharma start-ups with up to 50 employees or CROs with up to 150 employees
- QM, Regulatory Affairs or documentation management teams looking to improve upon their existing TMF operations
- You have reached the end of preclinical studies, are in the approval phase (IND/CTD) or in phase I of your clinical trial
Avoid chaotic audits and downtime during an inspection. Ultimately leave more time for the essentials:
Accelerating the speed of medicines to market.
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What experts say about us
‘After a long career in the pharmaceutical industry in various companies, both in commercial and development environments, I have seen the complexity of the entire drug manufacturing process increase along with regulatory requirements. Many companies were struggling with isolated IT solutions and the major challenge of how to apply or adapt the established IT systems in the necessary interaction with more and more external business partners to fulfil regulatory requirements at the same time. The young start-up Docuply offers a very simple and at the same time very flexible solution for this, which is immediately ready for use thanks to its cloud architecture.’
