OpenClinica Customer Success: Signifikans CRO
Challenge
Founded in 2002, Signifikans is a contract research organization (CRO) that offers a full statistical analysis service, information technology (IT) solutions for clinical trials, and clinical data management services. Signifikans wanted to improve patient engagement and protocol adherence for a sponsor in the early phase of a decentralized clinical trial (DCT) for a food supplement.
Since participants would be administering the supplement themselves at home, Signifikans wanted to offer a flexible, easy, at-home digital experience to improve patient engagement throughout the DCT.
Solution
Signifikans’ customers depend on it to deliver high-quality, efficient, and cost effective clinical studies. To reinforce this commitment and boost patient engagement, Signifikans chose OpenClinica Consent™ for secure digital consent and Participate™ for electronic patient reported outcomes (ePRO).
Results
OpenClinica Consent improved engagement in the DCT by simplifying, streamlining, and automating electronic informed consent (eICF). Highlights include:
- The seamless distribution of informed consent forms via email or phone.
- The ability of participants to conveniently sign electronically after reviewing study materials.
- Compliance with HIPAA, GDPR, 21 CFR Part 11, ISO 27001, and SOC 2.
- Documents reaching participants promptly.
- All personal information was safely hidden.
- Electronic messages supported various formats like photos, tables, and videos.
- Participants gained instant access to signed informed consent, eliminating the need for printing.
- Sites signed off within the system, with information visible in the participant list.
- The module’s versatility extends to other forms like additional informed consent and GDPR forms.
OpenClinica Participate helped keep remote participants engaged while saving time for sites, staff and participants. With Participate, Signifikans used mobile phones to collect data from participants who took the treatment at home and to improve clinical research compliance. Highlights include:
- Participants received a text message every week with a link to a quick questionnaire. This questionnaire was sent automatically from the start of the study until the end of the treatment.
- Participants could answer screening surveys on their phones.
- Every day, we reminded participants to take their medication, and they could confirm if they did.
- Every week, we sent updates directly to the study team.
- Participant data went straight to the electronic data capture (EDC) system and could be checked on the study dashboard.
In the words of Andreas Habicht, the CEO at Signifikans,
OpenClinica Consent is a very well designed and created system, offering noticeably simple ways to improve the clinical trial process! The system is very intuitive and easy to implement in all trials. A big plus is the ease of authentication, which will certainly facilitate training for sites and patients, the ability to add photos or videos to the form, and the availability of a PDF version for the patient.
OpenClinica Participate ePRO saved time for everyone – patients, sites, and the study team. The system was easy to use, and both medical staff and patients did not need to be tech-savvy.”
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