Gouya Insights - Services

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.

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:

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 event
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)