Year-on-year life sciences organisations are being required to make publicly available more clinical research information and data. Trial sponsors often struggle to keep track of these evolving regulations and choose to outsource this work. For over a decade, Vak IT Solutions has continuously evolved Clinical Trial Disclosure (CTD) services allowing our clients to keep pace with – or even get a step ahead of – regulatory requirements.
Vak IT Solutions offers a full suite of end-to-end CTD services. We can provide advice on requirements, build solutions and deliver operational activities. From protocol registration through to results posting, preparation of plain language summaries (PLSs), and redaction and anonymization of documents and datasets, we have your clinical and regulatory teams covered.
Trial disclosure requirements exist for most trials in patients. The US and EU governments maintain registries where protocol information is submitted, maintained, and updated from a study’s initial approval through study completion. Many other countries maintain local registries, requiring oversight for ensuring global harmonization and compliance. The introduction of data sharing and anonymization, now becoming a focus of scientific journals, patient advocacy groups, and other organizations, further broadens the transparency landscape, and reinforces the need for sponsors to proactively implement transparency policies.
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Market leader in disclosure services: Disclosure services have been a central part of Vak IT Solutions business strategy for over a decade and we currently support over 50 customers in this area, including many leading global pharmaceutical companies. Our teams advise clients on the specific disclosure requirements for each study and prepare quality deliverables that are compliant to regulatory timelines.
Vak IT Solutions Global Disclosure Intelligence: Vak IT Solutions supports country-level disclosure intelligence and compliance. Currently we provide advice for global registry requirements for more than 30 countries. This is applied to analyze the disclosure requirements for each study (mandatory vs. voluntary posting requirements), and to understand the implications of non-compliance. This repository is continuously updated as regulatory disclosure requirements change.