Data is the most crucial asset of any clinical trial and hence, sponsors cannot jeopardize collecting clean fit-for-purpose data. However, generating high-quality clinical data is far from straightforward, especially if you do not have the appropriate in-house expertise.
Planning your data strategy can ensure a high-quality evidence package and increase the chances of successful clinical development. It also increases the possibility of gaining a return on investment and improves the chances of new therapies reaching the patients.
On the other hand, without a data strategy your trial may experience innumerable delays and can fail to obtain regulatory approval. Additionally, it is vital to plan your data strategy and trial design as soon as possible, preferably prior to starting Phase 1 and ideally as you transition from non-clinical to clinical studies. Early planning and consideration of the entire development pathway can significantly benefit your clinical programs.
Cytel’s new eBook on Data Management discusses the many challenges related to data and provides insights on how to implement an optimized data strategy that can help you bring effective new therapies to patients. Our industry experts in Strategic Consulting, Clinical Research Services and Data Management teams cover the following topics:
1. Why is it important to prioritize the planning of your clinical data strategy 2. Key considerations in planning your clinical data strategy 3. The value of planning a program-wide data strategy, earlier 4. Planning Phase 1 – Mitigating unknown risks before they arise 5. Planning Phase 2 – Ensuring a high-quality evidence package 6. Top tips on optimizing your data strategy planning