Operational Services for Clinical Development

Providing operational services to clients on drug and medical device development, including clinical study protocol development, clinical trial project management, medical writing, data management, biostatistics, pharmacovigilance and quality assurance.

Gouya Insights Infographic Services Strategic Consultancy, Operational Services Operational Consultancy

Your Clinical Development Operations Team

Gouya Insight’s operational services offers high-level project management to create and implement the roadmap for drug and medical device development. As partners in your clinical development projects, we work alongside your team to prioritize safety, compliance, and operational excellence. We also advise on current regulations and market dynamics. Discover how Gouya Insights can ensure success in your clinical trials.

Customized Clinical Design & Implementation

Moving your project forward alongside your team

Gouya Insights provides operational services that focus on the day-to-day execution and management of drug and medical device development, addressing the evolving landscape of the biotech industry and the cutting-edge demands of latest medical research. These task-oriented services contribute significantly to the successful implementation of the clinical development plan, ensuring that clients pioneering innovation receive unparalleled support.

These services are offered alongside our operational consultancy services to bring together high-level strategies with daily operation tasks:

Risk & Quality Management

Systematic process for the assessment, control, communication and review of risks and safety in the clinical development

In clinical development, Gouya Insights prioritizes risk & quality management for operational excellence. Our systematic approach ensures seamless trial execution, covering meticulous risk assessment and safety protocols, strategic control, and stakeholder communication. We commit to quality control, data integrity, and patient-centric practices. Expertise in processing adverse events adheres to EudraVigilance reporting, actively monitoring risk-benefit assessments for real-time insights. Choosing Gouya Insights means entrusting your clinical development to a team strategically implementing risk and quality management for precise, integrity-driven trials and continuous improvement.

Third Party Vendor Management

Oversight of third party vendors to support of your clinical study

In drug and medical device development, Gouya Insights excels in crafting tailored strategies for third vendor selection. We identify the best match, orchestrate formal processes, and employ a competence-based approach. With extensive experience, we bridge strategic planning and execution, ensuring a holistic approach aligned with development goals, and adhering to proper regulations such as ICH E6 (GCP), ISO 14155, FDA 21 CFR Part 50, and EU Regulation No 536/2014. Choosing Gouya Insights entrusts your operational intricacies to a team dedicated to elevating development endeavors with precision and expertise in the dynamic landscape.

Comprehensive Medical Monitoring

Responsibility for the conduct and reporting of clinical trials

Navigating clinical trials requires a strategic and vigilant approach, and Gouya Insights leads in medical monitoring, taking responsibility for trial conduct and reporting. Beyond mere oversight, we strategically orchestrate critical components, emphasizing partnerships and value creation. Our commitment includes meticulous oversight, quality assurance, and thorough vendor control for seamless trial functioning. In issue and Corrective and Preventive Actions (CAPA) management, we swiftly address challenges, conduct audits, and proactively mitigate risks. Join us in medical monitoring for a blend of strategic oversight and operational excellence, elevating your drug or medical device development trajectory.

Medical Writing​

Our medical writers prepare concise, well-researched, GCP-compliant documents, including

Our specialized team of medical writers operates at the intersection of exactitude and strategic thinking, contributing substantially to the foundational elements of your scientific pursuits. We meticulously prepare concise, thoroughly researched, and GCP-compliant documents, including those related to medical and European patents.This includes the nuanced construction of briefing books, clinical study protocols, and clinical study reports, ensuring the highest standards of scientific rigor aligned with your clinical study publication strategies.

Expert Biostatistics and Data Analysis

Our biostatistics team analyses and supports the interpretation of your clinical trial data

Gouya Insights applies a strategic biostatistics and data analytics approach. Our team actively contributes to developing precise clinical study protocols and comprehensive statistical analysis plans. Specialized in conducting interim and final data analyses, we provide crucial insights for informed decision-making. From facilitating life-saving vaccines to shaping strategic approaches in medical and biotechnology, we’ve been an indispensable partner. Gouya Insights partners with you for biostatistics and data analytics aligned with your strategic goals, providing a deeper understanding of your data.