Clinical Trial data services
Your clinical trials support partner when needed
We offer professional statistical and data management input. review, advisory and facilitation of the development of key clinical trial essential documents in our respective specialisms. We aim to enable your research where and when it is needed, in particular, during the setup phase of ciinical trial.
What sets Aligns apart is our extensive experience across different clinical trial phases and therapeutic areas. Our main aim is to accelerate timelines.
Some aims
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To provide services that facilitates investigators and sponsors in the setup phase of a clinical trial in the areas of statistical advisory and data capture .
- To provide tools to ensure that reliable data is maintained throughout the trial life-cycle by providing or advising on electronic systems to streamline data management and monitoring.
- To provide services/advice that utilise technology appropriately in this exciting, evolving environment, where AI can play a part to improve efficiency.
- To be adaptive to investigator and sponsor needs, prior to funded/contractual staff being allocated, or getting up to speed or providing speedy advise to avoid delays.
- To prevent early/avoid protocol amendments by giving experienced viewpoints up-front prior to regulatory submission which can cause frustration for the trial teams and for site staff.
Why us?
- At Aligns, we understand the nuances, challenges, and importance of each stage of the research process.
- We acknowledge investigators frustrations regarding setup phase delays.
- We believe that we can reduce time during setup by utilising our experience where and when it is needed.
- We have worked with many Sponsors, both commercial and academic.
- We have liaised with third party vendors on behalf of Sponsor organisations that require specific contractual arrangements regarding data provision and ensure contractual delivery in accordance with trial timings and regulatory requirements.
- We have participated in many regulatory inspections and Sponsor audits, and carried out internal audits to ISO 27001 and 9001 standards.
- Since the early 1990s we have written standard operating procedures in our areas of expertise and across other areas to capture regulatory requirements for all types of clinical trials.
- We have represented major CTUs at national meetings.
- We have a significant number of publications in peer reviewed journals.
Our statistical and database advice plus our input to the creation/review of essential regulatory documents can contribute to the success of your current or future research project.
