The world of clinical safety and efficacy research is inseparable from CROs, which play a key role in its execution, ensuring that products reaching the market meet safety and efficacy standards.
For laboratories, manufacturers or marketers, the relationship with the CRO is essential to design and execute studies that meet their needs and support the product in terms of regulatory compliance and commercial claims.
Dr. Goya Análisis has innovated with the integration of its CRO and the Complutense Medical Center, both part of the same business group. This facilitates full coordination between the project managers, who manage the design and final reports, the healthcare professionals, and the technical and recruitment teams.
This integration allows the developer easy access to multiple medical specialties, advanced equipment (operating room, Rx, ultrasound), and technological services such as microcirculation analysis, epidermis vs. dermis thickness, SLEB, echogenicity or superficial and deep fat. All this, with total transparency, continuous access to the project managers and to the executing team during the design, execution and reporting phases.
This business model provides important advantages:
- Access to a Diversified Participant Base
Access to a Diversified Participant BaseThe integration of a medical center allows Dr. Goya Analysis to recruit participants with a wide range of demographic profiles and health conditions. The ability to include individuals of diverse ages, genders, ethnicities, and medical conditions allows for a more complete and accurate picture of the effects of a treatment or intervention.
Advantage for Laboratories:
- Representative results: Inclusion of a diverse population increases the external validity of the studies, which means that the results can be better applied to the general population.
- Detailed segmentation: Access to specific subgroups allows for detailed analysis, which is essential for market research and marketing strategies, and can identify which demographic groups respond best to certain treatments, which can influence the direction of future research and product development.
- Synergies between Medical Treatments
Combining medical treatments within the clinic allows products with multiple medical benefits to be studied. For example, treatments for chronic diseases can be evaluated not only for their long-term efficacy, but also for their effects on patients’ quality of life. This synergy allows for a more complete and holistic evaluation of products.
Advantage for Laboratories:
- Comprehensive data: The ability to evaluate multiple aspects of a treatment in a single study provides a comprehensive view of its effectiveness and safety. This is essential for developing treatments that not only address the primary disease, but also the patient’s comorbidities and overall quality of life.
- New applications: Identifying additional benefits and potential new applications for existing products can open up new market opportunities. This ability to discover new therapeutic indications is a major attraction for laboratories seeking to maximize the value of their products.
- Resource Optimization and Cost Reduction
Sharing infrastructure, personnel and equipment between the medical center and CRO operations reduces operating costs and optimizes resources. This synergy makes it possible to offer more complete and efficient services without significantly increasing costs, improving the financial sustainability of studies and reducing the time required to bring a product to market.
Advantage for Laboratories:
- Reduced costs: Lower costs in conducting clinical studies means that laboratories can allocate more resources to other critical areas of development and innovation. This cost reduction can also translate into more competitive prices for final treatments.
- Increased efficiency: The speed and efficiency in the execution of studies accelerates the time to market of products. This is especially important in the pharmaceutical industry, where time is a critical factor in competitive advantage and R&D payback.
- Improved Participant Retention and Fulfillment
The medical center provides a comfortable and professional environment that enhances participant satisfaction and engagement in clinical studies. Additional wellness services can serve as incentives for participants to better adhere to study protocols. A comprehensive care environment not only enhances the participant experience, but also increases the quality of data collected.
Advantage for Laboratories:
- Increased adherence: Reducing the attrition rate and improving adherence to study protocols means that more complete and reliable data can be obtained, and facilitates long-term follow-up, crucial for assessing the effectiveness and safety of treatments.
- Positive experience: Increasing participant satisfaction improves public perception of the study and the product. Satisfied participants are more likely to recommend participation in future studies and to trust the laboratory’s products.
- Innovation in Study Design and Methodology
The integration of a medical center allows Dr. Goya Análisis to design studies that address medical issues in a comprehensive manner. This encourages creativity and the formulation of novel hypotheses, allowing the exploration of new areas of research. Innovative studies are essential to advance medical knowledge and develop cutting-edge treatments.
Advantage for Laboratories:
- Robust studies: The ability to obtain more complete and valuable data can differentiate your products in the marketplace. Well-designed and robust studies provide compelling evidence of the effectiveness and safety of treatments, critical to market success and regulatory compliance.
- New opportunities: Discovering new therapeutic applications and improving existing ones can broaden the laboratory’s product portfolio and increase its competitiveness.
In short, coordination between the CRO and the research center is crucial for the success of clinical research, and Dr. Goya Análisis’s approach has been to integrate both entities into the same business group with the aim of achieving three main objectives: access by the promoter to the project managers and professionals responsible for execution, recruitment of a population with diverse pathologies that regularly attends the medical center, and cost reduction.
Iván Parra
Commercial Director
Dr. Goya Anlysis