The traditional CRO model for running clinical trials is costly and inefficient.
Are you ready for fixed price, high performance digital clinical trials?
Traditional CRO approaches to running clinical trials are antiquated. They rely on decades-old inefficient processes, technologies and practices that result in missed recruitment goals and constant cost overruns.
What is needed is for clinical trials to be efficient, inclusive, on-time and on-budget.
Validcare has re-engineered the clinical trial process, replacing antiquated practices and processes with an end-to-end digital, high performance, turnkey solution for Sponsors – regardless of study type, therapeutic area or product category.
With Validcare, Expect Results…Not Excuses
Validcare is different. Every CRO says that, though, don’t they? So why are we different? Validcare was designed from the ground up to be as efficient as possible. The Validcare Digital 1st Experience was designed to incorporate as much direct data entry as possible reducing on-site time to a minimum. It provides you with superior performance, visibility and control from trial design through database lock, de risking investment and achievement of regulatory timelines irrespective of therapeutic area or geography.
But we have therapeutic experience covered from nutraceuticals to CAR-T therapy and everything in between.
Validcare’s Clinical Trial Platform as a Service provides an optimized, turnkey solution focused on results and eliminates avoidable trial costs and delays associated with inefficient software, data management and staffing.
Transparent. High-Performance. Low-Maintenance. Turnkey.
Real World Evidence – RWE
Real World Evidence (RWE) is increasingly recognized as an invaluable research tool that provides a robust and cost-effective core element to any product development plan. Life sciences companies are embracing new strategies, partnerships, and technologies and with them the application of RWE methodology throughout the development lifecycle. As a result, they can realize fresh opportunities to discover, optimize, and demonstrate value even during traditional early phase research.
Validcare’s expertise in RWE coupled with our unique Digital 1st Experience takes our offering to new levels of efficiency and reliability for any type of RWE study including non-interventional (NIS) or observational, registries, post-approval surveillance/monitoring, Post-Approval Safety Study (PASS), patient preference studies, natural history studies and more.
The Validcare leadership team each have over 30 years of experience delivering medical device and in-vitro diagnostic studies. Our expertise coupled with the Digital 1st Experience, FirstPrin™ Trial Flight Plan and real-time regulatory updates means we can deliver bespoke solutions for your product anywhere in the world.
Recent changes to regulations in Europe have led to considerable and dynamic changes associated with the implementation of EU 2017/745 (MDR) and 2017/746 (IVDR) regulations for medical devices and in vitro diagnostics, respectively. Both regulations considerably increase the importance of collecting robust and good quality clinical data. Validcare’s unique offering means we can work with you to meet these new challenges without breaking the bank.
Strategy and Planning
Our expertise can help guide your strategy and develop the most cost effective path towards your product approval and reimbursement across global markets. From defining patient populations or initial clinical research strategy through to post-approval outcome measures or reimbursement strategies our global experience spans all phases of drug development.
Our experience has shown how we can help you can create an efficient “playbook” to define optimal inclusion/exclusion criteria, gain patient and site buy-in with simple, efficient data collection processes – all critical if a study is to be delivered rapidly and with minimal protocol amendments.
And finally, our proprietary planning software (FirstPrin™ Trial Flight Plan) allows us to model multiple scenarios with you to find the most efficient and cost-effective solution, tailored to your needs.