Off-Label Product Utilization
Cost-Effective Regulatory Submissions
Patient Education and Engagement
Studies and Trials
Clinicians value industry-provided education, training and innovative products. However, they understandably wish to preserve the fact and appearance of independence in their clinical judgments. Moreover, various laws, regulations and policies define permissible medical product marketing and sales activities.
In this environment, supporting independent studies by clinicians with large caseloads representing indications and product categories of interest can be a useful business development approach. Each clinical intervention typically represents several datapoints relevant to the safety, efficacy and improvement of a medical product. RegenMed provides the platforms, processes and transparent partnership allowing both the provider and the product manufacturer to benefit from those datapoints.
Healthcare manufacturers and distributors are prohibited from marketing their products for unapproved (“off-label”) indications. Conversely, practitioners are free to use products approved for one indication for a non-approved indication on the basis of their professional judgment.
Unfortunately, busy practitioners have little time, ability or incentive to develop safety and efficacy data relating to such off-label usage. This need not be the case. Patients, providers and industry all benefit from the generation of statistically significant data surrounding the safety and efficacy of off-label product usage.
RegenMed provides the platforms and processes allowing clinicians and their peers to capture, aggregate and derive correlations from such data in a burden-free and cost-effective manner
Healthcare product manufacturers must deal with an increasing number of complex regulatory submissions. They typically are complex, time-consuming and expensive; many are prematurely terminated with large sunk costs. For small and medium-sized manufacturers in particular, the challenges are daunting.
RegenMed provides cost-effective, compliant and integrated platforms and processes to support regulatory, IRB and medical ethics committee submissions in a cost-effective manner. The user-experiences for patients, investigators and sponsors are designed for efficiency, real-time data aggregation and reporting, electronic signatures, verifiable audit trails and other critical elements.
The busy clinical setting should be the best product development setting. Each case represents many dozens of potentially valuable datapoints. If properly captured, aggregated and correlated, those datapoints can yield powerful insights into safety, efficacy and clinical efficiency of devices, diagnostic tools, protocols and other products. Unfortunately, practitioners do not have the time, infrastructure or incentive to develop such insights.
RegenMed provides the integrated platforms and processes supporting manufacturer-clinician relationships leading to medical advances and product development in a low-burden, cost-effective manner.
Patient expectations are increasingly important considerations for manufacturers, payers, providers and other healthcare constituencies. Individual healthcare decisions are increasingly influenced by on-line research, provider reviews, advocacy groups, personal health monitoring, higher co-pays and television and radio “experts”.
Providers of course remain the critical point of contact for most patients. However, clinicians rarely have the time, training or incentive to explain to patients the comparative benefits of products used in their treatment plans.
The longitudinal, personalized engagement with a clinician’s patients is an important element of RegenMed’s platforms and processes. Product-specific real-world evidence generated by the clinician and RegenMed can easily be incorporated into that patient engagement.
By education and training, most clinicians are scientific. If they have the time and infrastructure to do so, even busy practitioners will undertake informal studies to investigate a clinical hypothesis.
This innate interest in clinical evidence, combined with the large caseload of a modern practitioner, provides a strong foundation for studies and trials correlations valuable for product manufacturers. RegenMed provides the clinical grade and turnkey platforms and processes allowing busy practitioners to undertake simple studies, or complex multi-center trials.
RegenMed serves as a trusted and value-added intermediator between clinicians and industry in the design and execution of those studies and trials.
Product manufacturers utilize detailing forces, educational and training events, medical conferences, journals and, increasingly, social media for HCP communications. Regardless of the channel, the most powerful messaging content combines evidence-based safety and efficacy data, ease-of-use and cost effectiveness. Ideally, that messaging is conveyed through clinical/scientific influencers and peer-to-peer.
RegenMed partners with clinicians around the world in generating real-world evidence from their everyday cases. Its turnkey and cost-effective platforms and processes provide several distinct channels for effective communications to clinicians and, through them, their patients.
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