The medical device industry has changed. Now more than ever, the winners will be determined by who has the most evidence…in effectiveness, safety, and value. A more stringent regulatory environment, new tax burdens, and an increasingly more challenging reimbursement pathway have converged to create a higher need for clinical evidence.
Emergent Clinical Consulting was developed to solve these strategic operational and commercial challenges by developing clinical programs that set Sponsors apart from their competition. By creating strategies that demonstrate value to all the stakeholders in healthcare (patients, caregivers, hospitals, and payers), Emergent Clinical Consulting can create a customized clinical development plan that translates to increased revenue for the Sponsor. Our services include:
STUDY START UP
Clinical Development Strategy & Planning
Pre/Post Market Study Development
Contract & Budget Development
Site Identification & Qualification
Regulatory Submission Preparation
Technology Identification & Implementation
On-Site Monitoring Services
Individualized Project Coordination
Legal Consultations (Medical Device)
Trial Marketing Resources
Recruitment Strategy & Implementation
Recruitment Material Development & Execution
Graphic Design & Branded Study Supports
Trial Marketing Resources
Traditional Contract Research Organization (CRO) bids are structured through unit-based pricing, a tactic that flattens and separates the number of hours of work performed from the completed task. The argument for this approach is that it provides the Sponsor with transparency of costs by limiting exposure; however, reports suggest that up to 25% of CRO revenue is generated from change orders. By providing a low initial estimate and relying on the inevitable changes during the study execution, some CROs can gain business and additional revenue beyond the initial estimates.
By contrast, the Emergent Clinical team bills on an hourly basis as opposed to a unit-based pricing model, which provides our customers with a level of transparency not typical in the clinical space. In addition to the pricing transparency, Emergent Clinical is structured to act as the virtual clinical development team in support of a Sponsor’s scientific and commercial development program. Unlike some large clinical service providers, the Emergent team brings a balance of both experience and value. On average, the Emergent Clinical Project Management Team has 13 years of industry experience and at an hourly rate that is 30% lower than staff rates within CROs. This model has been successful in supporting medical device manufacturers with both pre and post market studies while being conscious of constraints on budgets and resources.
Finding the Right Partner
Executing a competitive bidding process
Situation: Scientific Intake initiated a multi-center, clinical trial of the “Sensor Monitored Alimentary Restriction Therapy” or SMART device (a non-significant risk device) being conducted in the obesity space. At the time of Emergent Clinical Consulting’s involvement in the study, Scientific Intake was far along in the discussions with a CRO to support the upcoming study, but the CEO wanted to validate their experience in the space.
Action: Emergent Clinical Consulting reviewed Scientific Intake’s goals and initiated a competitive bidding process with three full service CROs and one independent staffing organization.
Result: By determining Scientific Intake’s core competencies, current clinical needs and strategic clinical plan, an alternative full-service vendor was identified and selected. This translated into a 23% cost savings over the original CRO’s proposal and allowed the company to identify a more experienced partner. In this case study, Emergent Clinical Consulting served as Scientific Intake’s clinical lead during the operational implementation and oversight of the study. When asked about his experience on implementing a process for vendor selection, Bill Longley, CEO of Scientific Intake stated: “I now know that finding, selecting and the ongoing management of a CRO is the most important decision a medical device company can make. The decision is complex, and I cannot imagine trying to do this without a methodical process to ensure that we setup the right structure for the trial. As an entrepreneur, there are a lot of things that keep me up at night, but our process for vendor selection was not one of them.”
Saving Time & Money
Qualifying a clinical plan
Situation: A device company with a next generation sports medicine product contracted with Emergent Clinical Consulting to determine if the current study criteria were aligned with their study enrollment estimates.
Action: Emergent Clinical Consulting conducted site qualification visits focused on reviewing the existing study criteria and the site’s available patient population based on the study inclusion and exclusion requirements.
Result: After conducting site qualification visits, it was discovered that one of the study criteria that would have contributed to the primary endpoint was too restrictive to the patient population. It was determined that the original physical assessment would not have identified the target patient population and would have contributed patients with a more advanced degenerative disease. The protocol was amended prior to initiation to better identify the target patient population through a more accurate physical examination. This amendment ultimately reduced the time of active enrollment. By proactively introducing the amendment, the sponsor avoided an extensive enrollment phase, which would have contributed to approximately $1 million in additional fees for the Sponsor and an additional year to reach the market.