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What solution does Datacapt provide to Spincontrol for their clinical studies?
“Using Datacapt means showing the image of a company that is moving forward” - Christine Perrier-Gillioën, Quality Assurance Director
Eurofins Spincontrol, a CRO specialized in cosmetic testing, is recognized for its innovative approaches, but also for its expertise in instrumental techniques. With a strong presence in France and abroad, Eurofins Spincontrol ensures flawless quality in all its sites.
Context
Before Datacapt managed Spincontrol’s Observation Books, Spincontrol had no direct visibility into its studies’ progress. A lot of time was wasted filling in and checking paper observation books. The management of this documentation during and after the studies was also time-consuming, sometimes cumbersome, and did not allow for the rapid implementation of multi-center studies. The preservation of personal data had to be proven by compliance with internationally recognized standards.
The challenge
Two major points: data accuracy and timeliness
Paper CRFs do not allow for centralized data control and review, nor daily reporting on the progress of studies.
Datacapt allows teams to save considerable time. From now on, all data is accessible in real-time and can be exported in one click in several formats (Excel, PDF, CSV).
The ability to create and reuse CRF models previously created for each type of project allows Spincontrol to quickly set up studies and forms.
The solution
The choice of Datacapt for efficacy and safety studies
Spincontrol was looking for a flexible and secure solution for cosmetic clinical studies that would allow access to all data in real-time at one or more centers. The company wanted a centralized system that was easy to use for its staff who manage daily clinical safety and efficacy studies and collect, verify and monitor data.
From the first demonstration, the team was convinced that the Datacapt platform and the eCRF module were the essential tools they needed.
The team was trained on the platform in just a few hours.
Tangible benefits
Increased compliance
The switch from paper to eCRF was quickly adopted by all staff: study coordinators and the quality department in charge of complete control of data processing and study files. The transition was appreciated, as the use of the Datacapt platform boosted the dynamism of the teams, volunteers, and clients by simplifying certain processes and saving time.
The compliance of the Datacapt platform with various international standards and regulations ( GDPR, HDS, ISO27001, FDA 21 CFR PART 11…) also enables Spincontrol to ensure the protection of personal data and the security of study data. These regulatory guarantees allow responding precisely to the audits of the most demanding clients
.
Successful results and benefits of Datacapt
Within a few months, the teams were able to observe time savings in the construction of eCRFs, data collection, monitoring, and analysis.
All studies and data are accessible at any time and allow for fast and efficient real-time monitoring for all stakeholders.
The digitalization of eCRFs allows Spincontrol to carry out multi-center studies with other CROs selected by the sponsors. Thus, the Datacapt platform increases the capacity to select individuals who meet the demanding criteria of the study protocols.
The Datacapt eCRF also meets Spincontrol’s CSR policy in every way, eliminating paper consumption and printing.
Spincontrol is looking to rapidly implement the eCRF module in its other sites around the world to improve processes, save time and enhance quality.
Studies yearly
Days saved monthly
Paper reduction
Before
- Little visibility on the progress of multi-center studies
- Processing and logistics of paper CRFs
- Lack of quick and synthetic visualization of each subject’s follow-up
- Time-consuming completion of paper CRFs
After
- Real-time visibility of multicenter studies via a single platform
- Complete dematerialization of documents (eCRF)
- Centralized and secured data collection
- Processes improvement
"The construction of the eCRFs with Datacapt and their use in the studies was very intuitive because the platform is easy to use and really adapted to the different studies conducted by Spincontrol. The adoption of the platform by all the teams was rapid."
Conclusion
“Using Datacapt means showing the image of a company that is moving forward.” - Christine Perrier-Gillioën, Quality Assurance Director
