DELLMED CONSULTING

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Clinical Research Documents
Go to PITFALLS in RANDOMIZED MULTINATIONAL CLINICAL TRIALS

PITFALLS in RANDOMIZED MULTINATIONAL CLINICAL TRIALS

By clicking on the circle you can download this ppt presentation, then, feel free to customize it to your need, for internal training of your Clinical Trial Teams

Go to Responsibility and Costs matrix for multinational Clinical Trials

Responsibility and Costs matrix for multinational Clinical Trials

By clicking on the circle you can download this excel sheet, then feel free to customize for your trial

Go to CHALLENGES IN CARDIOVASCULAR DRUG DEVELOPMENT

CHALLENGES IN CARDIOVASCULAR DRUG DEVELOPMENT

By clicking on the circle you can download this ppt presentation, then, feel free to customize it to your need, for internal training of your Clinical Trial Teams

Go to DUE DILIGENCE

DUE DILIGENCE

By clicking on the circle you can download this ppt presentation, then, feel free to customize it to your need, for internal training of your Clinical Trial Teams

Gilles DELLA CORTE, MD

27-year experience in Clinical Research.
From Phase I to Phase IV

Medical Doctor, Board Certified Cardiologist, with 37 years professional experience, 27 of which in the Pharmaceutical Industry, I bring a broad experience in Clinical Development/Project Management from Phase I – Proof of Concept to Life Cycle Management acquired both in Pharma companies (Corporate and affiliates), in CROs or Biotech Start-ups. I am a result-oriented senior pharmaceutical executive recognized for being a strong team player and appreciated for my active listening capacity, combined with an assertive and analytic communication style.
For more details, please click on the icon "CV" at the top right of this page.

SERVICES

What I can do for you

CLINICAL DEVELOPMENT

Consultancy and writing of Clinical Development Plans, Study Design, Study Concept Sheets and Protocols, Clinical Study Reports

DUE DILIGENCE

Conduct and Coordination of Due Diligence Teams and advise on clinical aspects of the file

OUTSOURCING

CRO selection and supervision from Trial Feasibility to Clinical Study Report delivery

REGULATORY

Clinical input and global coordination for Regulatory Document writing: Investigator Brochures, Briefing Books for Health Authorities (FDA, EMA), Pediatric Investigational Plan, Clinical Overview and Clinical Summaries for CTD, NDA, Development Safety Update Report

SAFETY

Coordination and Participation to data Safety Monitoring Committees, SAE narratives, input on Risk Management Plan and Periodic Safety Update Report

ECG CENTRAL READING

Central reading of ECG records (Board Certified Cardiologist)

MEDICAL WRITING

Trial Protocols, Clinical Study Reports, Investigator Brochures, Development Plans

Contact me

Testimonials

References and Partners