Operational Consultancy Services for Clinical Development

Providing operational advice and guidance to clients and their internal teams on drug and medical device development, including project assessment, process optimization and documentation, and risk evaluation.

Gouya Insights Infographic Services Strategic Consultancy, Operational Services Operational Consultancy

Your Operational Consultancy Team

Gouya Insights excels in operational consultancy, providing strategic oversight for drug and medical device development. Our approach optimizes efficiency and risk management through strategic planning and decision-making. We offer expert advice throughout clinical trials, ensuring quality, compliance, and successful execution. Explore our comprehensive consulting services below.

Customized Clinical Development Strategy

Evaluation and assessment of your study's clinical development operational strategy

Beyond high-level planning, we provide strategic oversight integrated with practical operational insights. Our strategy ensures quality assurance in clinical operations and coordination between sponsor and clinical operation, finalization of clinical study reports, publication, and application process. Choose Gouya Insights to turn your strategies into actionable success.

Data Management & Review

We create electronic case record designs with logic automated checks to simplify the generation of plausible data

At Gouya Insights, we consider data the linchpin of clinical success, driving our commitment to the highest standards in data management and review. Our comprehensive services cover the entire spectrum, from creating a medical data review plan and electronic case record designs with automated logic checks to meticulous data review and querying. Excelling in eCRF design and leveraging automated programming for robust medical data review, we ensure the integrity of your clinical data. Additionally, we swiftly confirm query resolutions, minimizing disruptions to trial timelines. Choose Gouya Insights for data management and review services that turn your clinical data into a strategic asset for success.

Clinical Project Assessment

Consulting on the strategic development of your clinical project.

Gouya Insights excels in clinical project management, ensuring precision and efficacy throughout the project lifecycle. Our approach involves meticulous assessment of project planning, timeline management, and support for cross-functional team meetings. With a focus on due diligence for investors and a guiding clinical roadmap, we know the impact precision and strategic insight can have on projects. Going beyond the consultancy aspect, we can also step in to provide operational services for project management. This includes coordinating and overseeing projects, and guaranteeing compliance with protocols and regulatory requirements.

Risk & Quality Evaluation

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

Gouya Insights prioritizes strategic risk & quality management, aligning with industry benchmarks like ICH E6 (Good Clinical Practice) and ISO14155. Our consultancy process covers risk assessment, control, communication, and review, ensuring alignment with FDA requirements. Our team of experts integrate strategic risk review and reporting, prioritizing ongoing enhancements. We are committed to quality control, assurance, and data integrity. Choose Gouya Insights for systematic precision, strategic vision, and excellence in risk & quality management, safeguarding your clinical development with continuous improvement.

Third Party Vendor Selection

Connecting strategic resources for optimal support of your project

Effective Vendor Management is pivotal for success in clinical studies, enabling a focus on core responsibilities. Outsourcing to experienced vendors aids in cost reduction, patient centricity, and efficient and effective outcomes. Gouya Insights aligns with regulatory standards, matching your project with vetted vendors that ensures strategic alignment and clinical development success.