HOW WE HELP
Protocol Risk Assessments
Good Protocol Risk Assessments are fundamental for high quality clinical trials. Correctly identifying critical variables up front, creating risk statements and then evaluating likelihood, impact and detectability are all vital skills.
Integrated Strategic Monitoring Plans
ISMPs are the critical link between your Protocol Risk Assessment and successful Central, Remote and Site Monitoring. Find out how they work and the 10 key elements to making cross-functional ISMPs effective and efficient.
CM tools and features
KRIs, KPIs and QTLs are all very powerful tools in Central Monitoring...if they are set up and used correctly. Get expert advice on which ones to use, when and why. Pick from the extensive libraries built into OPRA 5 or create new ones specifically tailored for your study.
Change is hard in every organisation. Resistance to change is a natural human reaction. To overcome it you need a compelling reason to change, a strong vision for the future, a solid plan to get there, and clear and open communication with everyone affected. We can help because we've successfully done it before for Sponsors and CROs.
According to our customers, our approach is different to other technology vendors in the sector. We know that technology will fail if the right processes aren't in place, and people can't or won't use them.
We know every organization is unique, each culture is different and everyone is facing their own specific challenges. That's why we take the following approach to every one of our customer engagements:
To find out how we can help you and your set of challenges, fill in the form below.