Working in partnership with sponsors, bringing simplicity and valid, long-term clarification to the obstacles delaying product clinical development, whether CMC and QA based or clinical, is the goal of any Certus program. This is particularly true for consulting, often a sensitive issue when dealing with internal teams.
Prior to the popularity of “virtual companies,” Certus Senior Management assumed roles for clients that would be generally performed internally, such as medical executives, quality assurance leadership, lead statistician, US Agent and vendor management. Certus has been described as an “executive” contract research organization, meaning many clients use Certus staff as senior team members for their organization, developing regulatory strategies. Our CEO has served as an Acting Medical Director for several large diagnostic companies and is functioning as Medical Monitor for other companies. Our VP of Quality Assurance has functioned as Acting Director of Quality Assurance for a US based diagnostics company and our Regulatory Director has functioned as US Agent for several international companies. Performing these roles puts Certus in a position to seamlessly transition to managing clinical programs, having already established familiarity with both product and project teams. We work closely, as trusted partners, streamlining procedures and maximizing both teams’ available resources. We can help fill management and executive responsibilities, on a temporary or long-term basis.
Most of Certus’ staff has worked together for over 15 years. This reduces risk, improves efficiency, and further differentiates Certus. The Certus team has worked across competences on imaging, diagnostic, therapeutic drugs, biotechnology and device products. Additionally, many Certus employees previously worked for sponsor organizations and their successful performance is why Certus sought their leadership. They know how to preempt regulatory crises, developing contingency plans and risk-balanced regulatory paths. Our management provides clinical development plans, systems analysis, SOP development and review, gap analyses, and education initiatives.
Identifying key areas that need to be addressed during product development sometimes requires more than one expert. Certus team members can organize or participate in product-specific panels and advisory boards, providing additional insight into clinical trial and product planning issues, particularly those in PET, radiopharmaceutical, and other imaging areas. Panels and advisory boards can identify areas requiring additional research, additional or better clinical endpoints and marketing strategies. Other frequent advisory board panel objectives include trial design strategy, developing high-level protocol outlines, potential product user questionnaires, expected outcomes, proposed clinical indications and expected utilization, as well as treatment consensus, discussion and debating a specific products development and regulatory strategy, GMP, and early study results.
When we organize expert panels, we use our extensive academic, professional and relationship networks, built from years in the industry. Our network includes a number of accomplished academic personnel, former FDA employees, and industry veterans who have the real, hands-on experience and the progressive vision necessary to discuss the issues.
Determining the most efficient pathway to market is a difficult task. With the number of potential regulatory pathways available to drug developers, having an expert who understands the system and can guide you through the submissions and appropriate product designation choices is priceless. Through close collaboration with your team and a careful but honest approach, Certus International knows how to plan a product’s research and development path. Though we don’t perform nonclinical studies ourselves, we know which ones are necessary for your product development and submissions and can guide you. Once data are collected, we are able to incorporate the information into an IND submission, writing, formatting, and submitting the information to FDA in CTD format.
Resource planning, particularly at early stages of a company or academic center’s product development, is extremely important. Investors and grant applications often require a development plan outline, with timelines, cost estimates, and contingency plans. Let Certus put this information together for you, using our industry experts. This external verification is often highly regarded by venture capitalists and other investors. Certus has performed this function a number of times, helping clients who don’t have the resources to put together such a plan themselves and those who need external verification.
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