We are pleased to welcome Dr Nimita Limaye, Project Lead KRI Wiki, to the Cyntegrity team!
Key Risk Indicators (KRIs) play a fundamental role in managing risk, you could say they are the “traffic lights” of clinical monitoring. When appropriately selected and calibrated KRIs trigger the early warning signs that enable study teams to assess risks, mitigate them in time and prevent crises.
With our team of clinical experts we’ve been developing a “KRI Wiki”. Currently KRI Wiki holds over 260 KRIs, which can be filtered for categories such as risk type and risk event. As with other Wikis, we would like to give external collaborators the opportunity to grow and further optimise KRI Wiki together with us.
What is your role as a principal consultant to Cyntegrity?
Nimita: I was truly excited when Artem Andrianov reached out to me to lead the KRI Wiki initiative for Cyntegrity. Defining the right Key Risk Indicators (KRI) is one of the most crucial elements of Risk-based Monitoring (RBM) and the creation of a shared KRI Wiki is a path breaking initiative from Cyntegrity.
“A path-breaking initiative, bringing together experts from different organizations to pool their expertise and their experience.”
What exactly is a “KRI Wiki”?
Nimita: It is a dynamic, living repository of KRIs vetted by a panel of industry experts to support the implementation of a risk-based monitoring approach in clinical trials.
How does KRI Wiki help the industry?
Nimita: The industry is still evolving its RBM strategy today and KRIs constitute an integral part of the same. Every pharma company is struggling to figure out the right approach to dealing with KRIs. It is not just about identifying the right KRIs, but also defining them accurately, building the right algorithms, defining the right thresholds, outlining the right actions and owners, and finally accurately interpreting the implications of those risks in context with one or more associated risks.
What is the strength of KRI Wiki?
Nimita: KRI Wiki is a path-breaking initiative, bringing together experts from different organizations to pool their expertise and their experience towards creating a shared repository of knowledge.
“It is not just about identifying the right KRIs, but also defining them accurately.”
You Can Join the KRI Wiki Initiative!
If you are interested in being a part of this initiative and in learning, and sharing your expertise, kindly submit your application now: firstname.lastname@example.org
If you are lucky, you will be one of a chosen few! In pursuit of a model of data transparency, Cyntegrity plans on making this Wiki open access to all in the near future!
– Dr Nimita Limaye
About Dr Nimita Limaye:
Dr Nimita Limaye has over twenty years of experience working across the Pharma CRO industry, playing key leadership roles at companies such as Quintiles, TCS, SIRO, Altana Pharma, Cadila Healthcare, etc. She is also the past chair of the Society of Clinical Data Management (SCDM).