Gouya Insights Work Portfolio

20+ Years Experience in the Medical & Pharmaceutical Industries for Clinical Development

The Versatility of Our Skills

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.

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/SADE 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

Gouya Insights Work Portfolio

20+ Years Experience in the Medical & Pharmaceutical Industries for Clinical Development

The Versatility of Our Skills

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.

Project Portfolio

Drug Class: Biological

Therapeutic Indication: COVID-19

Gouya's Role: Clinical Project Management, Protocol Development, Medical Writing, Data Management, Document Management, Medical Device Vigilance

Drug Class: Medical Device

Therapeutic Indication: Aortic stenosis

Gouya's Role: Clinical Project Management, Protocol Development, Medical Writing, Data Management, Document Management, Medical Device Vigilance

Drug Class: Antifungal medication

Therapeutic Indication: gynecological infections

Gouya's Role: Clinical Development Lead

Drug Class: Biological wound dressing

Therapeutic Indication: Slow healing foot ulcers

Gouya's Role: Clinical Development Lead

Drug Class: Patent-protected solution for peritoneal dialysis

Therapeutic Indication: Endstage Renal Failure

Gouya's Role: Medical Data Review

Drug Class: Biological

Therapeutic Indication: fat graft

Drug Class: Biological

Therapeutic Indication: Hepatitis vaccination

Gouya's Role: Clinical Project Management, Protocol Development, Medical Writing, Team Structuring

Class: Medical device

Therapeutic Indication: Inflammatory bowel disease

Gouya's Role: Clinical Roadmap, Protocol Development, Third Vendor Outsourcing, Medical Writing

Class: Medical device

Therapeutic Indication: functional bowel disease

Gouya's Role: Clinical Roadmap, Protocol Development, Third Party Vendor Outsourcing, Medical Writing

Drug class: Biological / combination product / vaccine

Therapeutic indication: infectious disease

Gouya's Role: Due Diligence for Investors for Innovative Vaccine Technology, Clinical Project Management, Protocol Development, Medical Writing, Team Structuring

Drug class: Biological

Therapeutic indication: seasonal allergy vaccines

Class: Medical device

Therapeutic indication: aesthetics

Gouya's Role: Literature Research, Medical Writing, Clinical Evaluation Report

Class: Medical device

Therapeutic indication: nutritional toxins

Gouya's Role: Project Oversight, Clinical Project Management, Protocol Development, Medical Writing, Team Structuring

Drug Class: Small molecule

Therapeutic indication: Arrhythmia

Gouya's Role: Project Oversight, Clinical Project Management, Protocol Development, Medical Writing, Team Structuring

Navigate

Follow Us

Book Expert Hour