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MANAGE AND OVERCOME COMPLICATED TRIAL OPERATIONS AND BURDENSOME REGULATORY PATHWAYS
Transform the Clinical Development and Regulatory Strategy of Your Medical Product
Clinical Research Strategies assists new life sciences companies and healthcare IT entrepreneurs with their corporate start-up. We distill the complexities of regulatory and research disciplines into accessible terms for life science executives, entrepreneurs, and investors alike who play a pivotal role in the development and investment of a new product. Our goal is to improve your chances of clearing performance hurdles toward successful commercialization or exit.
We can help you manage and overcome complicated trial operations and burdensome regulatory pathways by:
- Leading engagement with regulators
- Selecting and managing your partners
- Providing quality assurance procedures and audits of your trial master file (TMF) for inspection-readiness
- Rescuing clinical trials fraught with cost over-runs or poor vendor performance
- Placing experts on your team to fill resource gaps
- Developing SOPs for clinical and quality departments or harmonizing SOPs from acquired business units
- Providing advice on emerging topics like clinical trial decentralization, remote monitoring, interoperability, and hybrid methods as technology and data standards continue to evolve
- Developing board-facing materials that substantiate costs, trial operations, and regulatory requirements
- Building start-ups from scratch to having fully negotiated provider agreements, office space, policies and manuals, talent on-boarding protocols, and more, all done with efficiencies in mind
Is this Your Start-up Year?
We know your first year or two can be the most stressful. We’ve been there ourselves more than once. Clinical Research Strategies is giving back to the underserved Life Sciences start-up community by sharing our network and advice for your toughest decisions and problems.
We’re here to help you tackle your biggest challenges and thrive.
LIFE SCIENCES CONSULTING SERVICES
Relevance in Research is Regulatory Science and Digital Transformation
As your business partner, we don’t push old school clinical trial methods because we aren’t afraid of regulatory reform and empowering you with sound advice about keeping costs and timelines as low as possible, harnessing technology to your benefit, and meeting the regulator’s needs.
Read Alethea’s July 2020 article, “Regulatory Science & Clinical Research: Where Do We Stand (And Where Are We Going)?” in Clinical Leader.
Want to Participate in the Development of a Cough Monitoring Wearable Device?
C-mo Solutions is an innovative company that has developed a wearable cough monitor. The cough monitor provides information about a patient’s cough to a healthcare provider. C-mo is interested in understanding how well users are able to receive and carry through instructions about using the monitor.
You do not need to have a cough to participate in this study.
The device testing will take place in early 2025.
LET’S TALK ABOUT YOUR PROGRAM
CRS advisors have been everywhere and can help you overcome the challenges of developing your product and clear the regulatory hurdles of bringing it to market.