Solutions / Industry
Converging Research and Sales Objectives.
Our services, systems and clinical networks offer turn-key, configurable solutions for industry sales, marketing and clinical research objectives.
Medical product manufacturers and distributors rely heavily on clinical data in all aspects of their businesses. IND’s and IDE’s, pre-market approvals, 510-K registrations, post-market surveillance, off-label indications, journal articles, conference presentations, patient communications, reimbursement and investor funding all depend on deriving statistically compelling correlations from product-specific healthcare data.
However, randomized controlled clinical trials –while remaining the gold standard of data-driven end-points – are lengthy and expensive. (They are even more so in the current COVID environment.) Moreover, maintaining consistency in RCT standards across multiple trial centers can be challenging, which severely limits patient enrollment, lengthens the trial time period, or negatively affects data quality.
The FDA, EMA, payers and clinicians are placing increasing emphasis on real world evidence, pragmatic clinical trials and other more efficient approaches to establishing the safety and efficacy of medical products and healthcare interventions. In addition to their substantially lower cost and shorter timelines, such approaches are relevant to a broader patient population, generate larger datasets supporting more correlations. Moreover, properly implemented, such approaches allow multi-center clinical evidence collection in a manner which accelerates patient enrollment and compliance, without degrading the quality of statistical conclusions.
Regen Med integrates independent scientific and clinical expertise, the flexible yet robust inCytes™ platform , excellent user experience throughout the data collection and analysis pathway, and deep business experience. Bringing these to bear on a client’s specific objectives yields demonstrable results in the context of sales/marketing goals, regulatory compliance, HCP communications, and/or patient engagement.
Recent Example of Our Work
We established a leading clinical registry in regenerative medicine with over 500 enrolled patients and 200,000 unique data points. Key components of the registry included product/device used, demographics, clinical methodology, human cell/tissue characterization, and patient outcomes. Over a dozen manufacturers benefited from either licensing the data, deploying their own custom studies upon its infrastructure and/or distributing their products to the participating clinical network.
Read The Latest
Use of Real World Data and Evidence By Industry
Published by admin
The implications of the COVID-19 pandemic for hospitals, HCP’s and patients alike are manifold and far-reaching. Evidence-based patient stratification ...
Align Post Marketing Surveillance and Post Marketing Clinical Follow-up with Product Lifecycle Management
Published by Michael O'Regan
The new EU Medical Device Regulation (MDR), which was scheduled to come fully into force in May 2020 ...
How to meet COVID challenges to MDR compliance while producing strategic growth benefits.
Published by Michael O'Regan
According to the most recent KPMG/RAPS survey of 230 medical device manufacturers, 83% of ...