Trial and Study Solutions
Center Point works with a wide range of clients including drug development, specialty pharma, and medical device companies. We also provide a wide range of solutions that support commercialization of pharmaceuticals, medical devices, and nutraceuticals.
Center Point lives and breathes a culture of compliance and harmony. Our standard operating procedures and processes are cGCP compliant. In addition, we work closely with internal teams to achieve commercialization goals in a timely manner that affords our partners a competitive market advantage.
At Center Point, it is all about helping you to increase efficiency, successfully transfer product knowledge, and strategically leverage market insights to drive brand value, market access and product reimbursement. Our clinical team is comprised of industry veterans with decades of experience, ready to support your regulatory and commercial goals. Here’s how we do it.
- Studies and RWE Analyses
Center Point supports two types of study tracks: pre and post regulatory approval. The CTRP® solution is used to secure reliable data for both. We also work with high prescribers to generate medical data for publication and address specific medical and outcomes questions.
Pre approval projects cover Phase 2 through Phase 3b studies intended to generate clinical data for scientific and medical awareness. These single-project studies may compare one product to another and enroll small numbers of patients for a comparatively shorter amount of time than the more advanced studies. Their purpose is to define patient behaviors, such as compliance and adherence, as well as identify potential signals. This information can be used to help develop better and more effective future protocols for larger, more costly and advanced development studies.
Post approval projects cover Phase 4, Real-World Evidence (RWE), retrospective database/medical record analysis and health outcome studies. RWE is collected from the medical and claims database in addition to longitudinal studies. The data from the databases and these studies is sourced from real-world treatment programs prescribed by the attending physicians to their patients, none of whom were paid to participate in a study. The protocols of these studies are designed to further identify appropriate patient utilization, product efficacy and impact on the industry quality metrics. In addition, these studies garner supplementary insights regarding dosing, adverse events, and other important product knowledge.
Real-World Evidence (RWE) and Analyses
Center Point’s expertise and participation helps partners generate reliable and credible RWE in a short amount of time and at less cost than competitors. We implement RWE observational studies, retrospective data-mining of existing information, and medical projects to document and validate patient adherence, appropriate patient utilization, health resource allocation, and achievement of quality metrics (HEDIS, URAC, CMS Five-Star Quality Rating System).
From the start, Center Point clarifies and provides the right value messaging documentation to address the needs of our partners. We create insightful and comprehensive analyses from real world data. For example, an analysis can address the data gaps for health economic outcomes information to support the appropriate positioning of a product, device, or procedure in therapy guidelines. All analyses can be used to support scientific conference presentations or articles intended for publication by a scientific journal.
- Health Economics and Outcomes Research (HEOR) and Comparative Effectiveness Research (CER)
Center Point provides the expertise to address the increasing importance of health economics, health outcomes, and value messaging in a product’s life cycle. We provide our partners with a plan to generate consistent value messaging publications, create economic dossier validation, and address the needs of formulary decision-makers.
Center Point is uniquely aware and understands the science of ‘value, cost and ROI’ in pharmaceutical and specialty products, biotech devices and medical procedures. When formally randomized and comparator trial data is not available, Center Point customizes a program for systematic data review and meta-analysis to determine a product’s value and comparative effectiveness within therapy categories.
- Market Access and Reimbursement Support
Center Point implements critical strategies and tactics to successfully guide partners through the maze of policies and metrics to gain timely market access and secure reimbursement for products, devices, and procedures. We do so by:
- Implementing specific short-duration studies with CTRP counseling and/or retrospective data mining of existing data
- Devising health outcomes and value messaging that addresses existing payers and branding concerns
- Defining the value of the product, device, or procedure in terms of cost and quality to meet the requirements of the health care reform in place and the associated shift in payer paradigm
- Generating evidence to support the value-based decisions of health plan payers and link the clinical impact of the product to appropriate quality metrics
- Industry Standard Quality Metrics Data
Often, adequate randomized controlled trial (RCT) data is not available to evaluate the utilization of a product, device, or procedure. To solve this problem, Center Point offers Retrospective Data Mining (RDM) and Medical Record Analysis.
Retrospective claims data is becoming more relevant to identify utilization trends and opportunities for patient care improvement. RDM analyses provide relevant information for patient and member populations in a real-world setting and also augment RCT data with valuable therapy insights.
Thoughtful medical record data capture and analysis can provide extremely useful and meaningful information to health plan decision-makers to compare the medical and pharmaceutical outcomes of a therapy.
- Scientific Publications
Center Point compiles, analyzes and reviews data to create scientific articles, posters, and presentations for submission to scientific meetings and/or peer-reviewed journals.
The documentation covers outcomes, cost, value and comparative effectiveness with the goal of winning the trust of managed markets decision-makers.