OUR STORY

Serendipity, enthusiasm and openness for innovation in healthcare, Gouya Insights retains passion for innovation and the trust of our customer as its core values.

OUTLINE OF ACTIVITIES

References to our clients can be provided upon request

• Therapeutic Indication: gynecological Infections
  Drug Class: Antifungal medication
  Geographic Region: Austria
  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

• Therapeutic Indication: Slow healing foot ulcers
  Drug Class: Biological wound dressing
  Geographic Region: Austria / middle Europe
  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.

• Therapeutic Indication: Endstage Renal Failure
  Drug Class: patent-protected solution for peritoneal dialysis
  Geographic Region: Austria
  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.

• Therapeutic Indication: fat graft
  Drug Class: biological
  Geographic Region: Austria
  Role: medical Writing (protocol, informed consent form (ICF))
  Key responsibilities: Literature search, developing final protocol and ICF for submission

• Therapeutic Indication: Hepatitis vaccination
  Drug Class: biological
  Geographic Region: Austria
  Role: clinical project management, protocol development, medical writing, team structuring
  Key responsibilities: Literature search, developing final protocol, and project plan, project management

• Therapeutic Indication: Inflammatory bowel disease
  Class: medical device
  Geographic Region: Austria / Germany
  Role: clinical roadmap, Protocol development, third vendor outsourcing, medical writing,
  Key responsibilities: Literature search, developing protocol, biomarker / endpoint selection

• Therapeutic Indication: functional bowel disease
  Class: medical device
  Geographic Region: Austria
  Role: clinical roadmap, Protocol development, third vendor outsourcing, medical writing
  Key responsibilities: Literature search, developing protocol, biomarker/ endpoint selection

• Therapeutic indication: infectious disease
  Drug class: biological/combination product / vaccine
  Geographic Region: EU
  Role: Due Diligence for Investors for innovative Vaccine technology
  Role: 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

• Therapeutic indication: seasonal allergy vaccines
  Drug Class: biological
  Geographic Region: Europe
  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

• Therapeutic indication: aesthetics
  Class: medical device
  Geographic Region: Austria
  Role: Literature research, medical writing, clinical evaluation report

• Therapeutic indication: nutritional toxins
  Class: medical device
  Role: project oversight, clinical project management, protocol development, medical writing, team structuring
  Key responsibilities: Literature search, developing final protocol and project plan, project management

• Therapeutic indication: Arrhythmia
  Drug Class: Small molecule
  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

TRAINING ACTIVITIES

PUBLICATIONS