Gouya Insights Work Portfolio
20+ Years Experience in the Medical & Pharmaceutical Industries for Clinical Development
The Skills to Fill Any Role
We have the skills to support any medical device or drug in clinical development.
Gouya Insights combines the expertise of many different industries to oversee and manage your clinical trial to market adoption. We are the intersection of industries and specialties. Our multidisciplinary team helps you reach your milestones quicker and on budget, so that you can help patients.
Get to Know Your Gouya Insights Team
Project Portfolio
Drug Class: Biological
Therapeutic Indication: COVID-19
Geographic Region: Austria
Gouya’s Role: Clinical Project Management, Protocol Development, Medical Writing, Data Management, Document Management, Medical Device Vigilance
Key Responsibilities: Literature search, preparation of final protocol and informed consent form as well as study specific manuals, project management, development of project plan, definition of responsibilities, team coordination, third vendor management, eCRF development, eTMF maintenance, safety management and reporting, quality and risk management
Drug Class: Medical Device
Therapeutic Indication: Aortic stenosis
Geographic Region: Europe
Gouya’s Role: Clinical Project Management, Protocol Development, Medical Writing, Data Management, Document Management, Medical Device Vigilance
Key Responsibilities: Literature search, compilation of final protocol (clinical investigation plan) as well as investigator’s brochure, informed consent form and other submission documents and manuals, project management and team coordination, eCRF development, eTMF maintenance, safety management and SAE reporting.
Drug Class: Antifungal medication
Therapeutic Indication: gynecological infections
Geographic Region: Austria
Gouya’s Role: Clinical Development Lead
Key Responsibilities: Creation of the clinical development program, seeking scientific advice from competent authorities, creation of clinical operations team and acting as main contact point between sponsor and clinical operation in providing oversight in the conduct of clinical studies and medical data review process, and supporting the finalization of clinical study reports, the publication and application process.
Drug Class: Biological wound dressing
Therapeutic Indication: Slow healing foot ulcers
Geographic Region: Austria / middle Europe
Gouya’s Role: Clinical Development Lead
Key Responsibilities: Creation of the clinical development program, seeking scientific advice from competent authorities, development of essential documents, creation of clinical operations team and acting as main contact point between sponsor and clinical operation.
Drug Class: Patent-protected solution for peritoneal dialysis
Therapeutic Indication: Endstage Renal Failure
Geographic Region: Austria
Gouya’s Role: Medical Data Review
Key responsibilities: Medical data review plan, medical data review of data listings, providing data query listings, confirmation of query resolution, participation in data monitoring board.
Drug Class: Biological
Therapeutic Indication: fat graft
Geographic Region: Austria
Gouya’s Role: Medical Writing (Protocol, Informed Consent Form (ICF))
Key responsibilities: Literature search, developing final protocol and ICF for submission.
Drug Class: Biological
Therapeutic Indication: Hepatitis vaccination
Geographic Region: Austria
Gouya’s Role: Clinical Project Management, Protocol Development, Medical Writing, Team Structuring
Key responsibilities: Literature search, developing final protocol, and project plan, project management.
Class: Medical device
Therapeutic Indication: Inflammatory bowel disease
Geographic Region: Austria / Germany
Gouya’s Role: Clinical Roadmap, Protocol Development, Third Vendor Outsourcing, Medical Writing
Key responsibilities: Literature search, developing protocol, biomarker / endpoint selection.
Class: Medical device
Therapeutic Indication: functional bowel disease
Geographic Region: Austria
Gouya’s Role: Clinical Roadmap, Protocol Development, Third Party Vendor Outsourcing, Medical Writing
Key responsibilities: Literature search, developing protocol, biomarker/ endpoint selection
Drug class: Biological / combination product / vaccine
Therapeutic indication: infectious disease
Geographic Region: EU
Gouya’s Role: Due Diligence for Investors for Innovative Vaccine Technology, Clinical Project Management, Protocol Development, Medical Writing, Team Structuring
Key responsibilities: Sponsor oversight, literature search, developing final protocol, and project plan, project management, risk management
Drug class: Biological
Therapeutic indication: seasonal allergy vaccines
Geographic Region: Europe
Gouya’s Role: Clinical Project Management, Protocol Development, Medical Writing, Team Structuring, Vendor Selection
Key responsibilities: Literature search, developing final protocol, and project plan, sponsor oversight, risk management
Class: Medical device
Therapeutic indication: aesthetics
Geographic Region: Austria
Gouya’s Role: Literature Research, Medical Writing, Clinical Evaluation Report
Class: Medical device
Therapeutic indication: nutritional toxins
Geographic Region: Austria
Gouya’s Role: Project Oversight, Clinical Project Management, Protocol Development, Medical Writing, Team Structuring
Key responsibilities: Literature search, developing final protocol and project plan, project management
Drug Class: Small molecule
Therapeutic indication: Arrhythmia
Geographic Region: Austria
Gouya’s Role: Project Oversight, Clinical Project Management, Protocol Development, Medical Writing, Team Structuring
Key responsibilities: Sponsor oversight, literature search, developing final protocol, and project plan, project management