Digital Solution Framework — the key to future trials at KCR
By Doug Bain, Chief Technology Officer at KCR
KCR has utilized some of the best technologies available in support of Sponsors, Sites and Patient throughout a clinical trial. In 2019, we took a further step to achieve a fully digital clinical trial lifecycle through the integration of cloud technology components that range from Feasibility, through recruitment, data capture (EDC + eCOA), trial management, eTMF, Drug safety management combined with leading edge digital dashboards.
The big step for KCR was that rather than using these different disparate systems to simply store data, we combined workflow and integrations to create an end-to-end framework that truly digitalizes our clinical trials.
Veeva are core component providers to our framework — KCR were the first CRO in Europe to adopt Veeva Vault Platform eTMF in 2014. Since then, KCR’s adoption of Veeva technologies as component parts of the framework has expanded to Vault CTMS, Vault CDMS/EDC and the Veeva Vault Quality Suite.
KCR are not stopping there. It is our firm belief that an end-to-end framework should involve our patients. Patients are core to all research we carry out. It is absolutely right that we provide the best level of technology based support to these patients. Today, this takes the form of eCOA / ePRO for capturing source data from clinicians or patients, wearables for capturing sleep quality and activity together with a number of other Decentralised Clinical Trial (DCT) methods.
One key element to the framework is its flexibility to support sponsor preferred components in specific areas. This means we are able to continue to offer an end-to-end digital solution with component elements swapped in. Through a structured approach, our cross functional teams manage adjustments to processes, interfaces and dashboard elements therefore maintaining the integrity of the end to end platform. Our consulting and technical teams advise sponsors on where components fit well or are incompatible and create inefficiencies.
The KCR Difference
One mistake often made in clinical research is to think that technology alone is a solution to a problem. This is not the case. To create an effective solution — in particular with modern configurable cloud solution like Veeva Vault Clinical — you need to invest in key areas. KCR have focused in 5 specific areas;
- Cloud — Technologies must be right from a proven measurable value perspective. KCR implement our solutions within a Computer Systems Validation process designed to not only validate the configured solution, but also to measure the before and after states ensuring new technology implementations are proven to be measurably better. If they are not cloud based or cannot be easily connected and reported against, then they are scored accordingly.
- Integration — KCR believe that non integrated technology create silos and cause delays. To tackle this, we implement cross study integrations between component parts of our Framework. This avoids unnecessary transcription and reconciliation steps.
- Processes — Generic processes won’t do for us. Unless your processes support your technology, the likelihood of gaining differentiating value from good technologies may be lost. Our processes go as far as acting as a driver of requirements to our technology configuration.
- Configuration — All modern cloud platforms are only as good as their configuration. This applies to EDC, CTMS and eTMF components in particular where we see significant improvement gains with the right ‘joined up’ configurations
- People / Training — Just in time, focused training that brings together the technology, the processes, the KCR specific configurations and our integrations to ensure that our staff and partners are subject matter experts in the application of our chosen technologies for our sponsors.
Sponsors that work with KCR and our Digital Solution Framework gain not just efficiencies, they also achieve transparency. Near realtime dashboards empower sponsor decision making across connected devices (laptops, tablets and mobile devices). In addition, we encourage our sponsors to become active participants in our digital lifecycle. Our role based digital framework provides the means for sponsor personnel to co-author, review and approve materials online as soon as they are published. This ‘one-team’ approach where traditional sponsor / CRO silos are broken builds trust whilst increasing transparency on the ongoing state of our clinical trials.
What is next?
KCR have worked on a direct to patient basis for a number of years with a sister company Curandus. This has enabled us to provide highly effective direct to patient research on large scale (10,000+) patient populations. Many of the methods we have applied such as Hybrid Decentralised Clinical Trials (DCT), Physician Referral Management and the use of Real World Data (RWD) are being rolled into our Digital Solution Framework ensuring patients routinely become an integral part of the digital clinical trial lifecycle.
KCR is a clinical development solutions provider for the biotechnology and pharmaceutical industries. We support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting and Placement. KCR operates now across five main regions: North America, Western Europe, Central Europe, Eastern Europe and Australia, with a main operational hub located in Boston, MA. Our strategic hub locations, technical capabilities and solution offerings allow for the optimized delivery of trial execution strategies to develop life-changing therapies. KCR offers access to an estimated population of 1.1 Billion people. For more information visit www.kcrcro.com.
*Originally published on LinkedIn on July 14, 2021*