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Decentralized
Trials
Putting the patient at the center of clinical trial design
Facilitating Decentralized Clinical Trials
Indisputably, with its numerous benefits, decentralized trials are a promising alternative in respect to the future of clinical trials and subsequent trial design.
Decentralized clinical trials have the ability to exploit technological developments to improve the patient experience and increase performance efficiency of clinical research. Whilst DCT's are fast becoming a real alternative to standard centralized trials, there still remains a lot of uncertainty and potential obstacles that can lead to failure. Surprisingly, there is no regulatory framework or guidance to support DCT's, which is why country specific intelligence is paramount. In addition, a decentralized trial must be sufficiently prepared and all additional considerations such as Direct to Patient delivery, technology, etc., must be submitted with the Investigational Medicinal Product Dossier (IMPD).
At SanaClis, we provided expert support throughout the entire DCT process, from early onset planning such as protocol development, IMPD submission, technology, Supply Chain, through to Direct to Patient and Global Home Nursing network.
Some of the key benefits for DCT's include:
- Patient-centric approach
- Accelerated patient recruitment and retention
- Increased speed of trial delivery
- Increased flexibility
- Real-time communication with patients
- Improved data diversity
- Limit the necessity or frequency of in-person visits
Why Partner with the SanaClis For Your Decentralized Trials?
- SanaClis Utilizes the latest Technology to support DCT's such as telemedicine, wearable devices, eConsent, eCOA, health records
- Expert guidance from all relevant perspectives across Clinical operations and Supply chain, crucial for DCT IMPD submission
- Entire in-house capabilities to fully support your Decentralized study, from Clinical Operations, Regulatory, Supply Chain (via privately owned global depot network in all major regions), Global Home Nursing network, sourcing, etc.
- Flexibility and experience to support decentralized and centralized hybrid models.
- Extensive country specific Regulatory Guidance to support DCT's
Meeting Evolving Needs
SanaClis Continues to Meet the Evolving Needs of the Sponsor, Whilst Overcoming Industry Challenges
