Gouya Insights Clinical Development Services
We leverage our multidisciplinary skillset and scientific and medical professional network to devise a sound clinical strategy for your innovative project, no matter the size.
Gouya Insights’ USP
Your partner from study design to study completion
Navigating the regulatory landscape can be challenging for a small-to-medium-sized medical device or pharmaceutical company. There are many approaches to clinical development, and you want to know the most cost-effective and strategic path to success. That’s where Gouya Insights becomes your expert partner. Regardless of the project scope or development stage, we’re eager to translate your innovation vision into a roadmap that streamlines your clinical development plan and puts your product on the quickest route to market approval with the highest clinical impact.
Areas of Expertise
Gouya Insights provides comprehensive strategic and operational consultancy services for drug and medical device development, helping clients to achieve their goals efficiently and effectively.
Strategic Consultancy
Strategic Consultancy
Providing strategic advice and guidance to clients on drug and medical device development, including selection of therapeutic indication, regulatory consultancy, regulatory compliance and market access.
Operational Consultancy
Operational Consultancy
Providing operational advice and guidance to clients on drug and medical device development, including project management, process optimization, and risk management.
Operational Services
Operational Services
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.
Our Clinical Development Services
Gouya Insights offers a full range of services to meet the demands of any clinical project, from protocol writing to project management, to vendor selection and beyond. We’ve worked with biotech start-ups as well as large pharmaceutical companies to successfully bring innovative medical and pharma products to market. Our success lies in our team’s agile and cross-functional way of working, helping break down silos and facilitating decision making, to jointly create streamlined strategies for your product.
We are more than consultants; we are your partners. We believe in your product and work passionately to make your goals a reality.
Clinical Development Strategy
Establishment and implementation of your product´s (drug, medical device) clinical development strategy:
- Indications’ analysis and prioritization
- Target product profile definition
- Competitive landscape mapping
- Risks and benefits analysis
- Clinical gap analysis
- Product regulatory strategy
Medical Writing
Our medical writers prepare concise, well-researched, GCP-compliant documents, including:
- Briefing books
- Clinical study protocols
- Clinical study reports
- Clinical evaluation reports
- Peer-reviewed manuscripts
Clinical Project Management
Successful implementation of the Clinical development plan. Project delivery from initiation to closure through extensive project lifecycle:
- Proactive project planning, definition of key project milestones and deliverables
- Management of project timelines and assistance in timely execution
- Management and support of cross-functional project team meetings and project updates communication
- Project coordination and oversight of activities ensuring compliance with protocols and all relevant clinical and regulatory requirements
- Set up and coordination of the study team
Risk & Quality Management
Systematic process for the assessment, control, communication and review of risks in the clinical development:
- Statement in ICH E6 (GCP) and ISO14155
- Risk identification & evaluation
- Risk control & communication
- Risk review & reporting
- Quality control, assurance, data
- Rights and patient´s well‐being
- Continuous improvement process
- Costly errors and wastage reduction
Data Management and Review
We create electronic case record designs with logic automated checks to simplify the generation of plausible data. Review and query clinical study data that impact patient safety or the overall conduct of the trial:
- Data management creation, review, and plans validation
- ECRF design and user acceptance test performance
- Automated programming for checks, medical data review
- Individual, aggregate data review
- MedDRA coded data listings review
Clinical Study Design
Use of a testing tool for drugs, devices, and techniques:
- Hypothesis, objective definition
- Sample size calculation
- Target population identification
- Robust and meaningful endpoint selection
- Ethical principles follower, scientific validity and integrity, medical relevance
Medical Monitoring
Responsibility for the conduct and reporting of clinical trials:
- Partnerships and value creation
- Oversights and quality assurance of clinical operations
- Vendor assessment and control
- Issue and CAPA management
- Conducting sponsor and investigational site audits
Safety
The pharmacovigilance and medical device vigilance team are reponsible for:
- Implementing and maintening the compulsory vigilance system
- Tracking and detecting safety signals
- Processing serious adverse events
- Reporting to EudraVigilance
- Monitoring and updating the risk-benefit
- Timely safety reporting to the relevant stakeholders
Third Vendor Selection
Outsourcing strategy for the ideal set-up for your company:
- Best match identification for the company and for the project
- Proposal process request
- Formal vendor selection process
- Bid-defense meetings coordination
- Experience and competence-based selection process
Biostatistics and Data Analytics
We apply statistical concepts to design and conduct effective clinical trials. We support our clients from protocol design through regulatory submission, while our biostatistics team analysis supports the interpretation of data:
- Input to the clinical study protocol or clinical investigational plan
- Randomization list and schedule preparation
- Statistical analysis plan
- Interim analysis and final data analysis
- Statistical reports
- Integrated Summaries of Safety and Efficacy (ISS/ISE)