The author
Christian Meyer, Chief Medical Officer, MD, PhD.
Experienced biotech executive. Interested in all aspects of clinical research leadership and management.-
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My most recent pieces
- “Clinical Project Leadership versus Clinical Project Management”
- How to allow researchers to continue exploitation of clinical data in a close down situation
- How to rise clinical development from lethargy
- 10 basic operational challenges in todays changing landscape
- The value of creating standards
- Who’s Afraid of Risk-Based Monitoring? – by GUEST AUTHOR
- Can we stop the spiral of clinical trial costs?
- Decline in clinical research studies stabilised – but can it increase again?
- “…wishing for the nightmare of a recurrence…”
- Controversies in the world of clinical trials
- “…making a dent in the universe…”
- People, processes – processes, people: Inseparable entities in industry sponsored clinical research
- “The seven habits…..” – Clinical Research Leadership principles
- EMA – a role model for respectful harmonization efforts?
- Is clinical quality assurance in early phase trials really important?
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Clinical monitoring Clinical research Clinical trial Contract Research Organization Execution Risk FDA GCP Good Clinical Practice Histogram Innovation Leadership Management Oversight Project Management Project team Quality assurance Quality Management Site Performance Site selection Start-Up Strategy Trial feasibility Trial Start-Up Tips Vendor Contracting Vendor Identification Vendor Selection Virtual Biotech Virtual business- Blogposts in Danish Clinical Trial Methodology Closing down a biotech company Electronic systems Enrollment performance Guest Authors Leadership Challenges Outsourcing Strategy Rescue Study Syndrome Risk-Based Monitoring Strategies Risk-Based Oversight of Clinical Trials Study Start-Up Trial feasibility Uncategorized Vendor oversight Virtual Biotech
Tag Archives: Execution Risk
“I want to feel the Sponsor!”
What happens when an outsourced project fails? Where to look for the cause? The easy way is to blame the organization that was contracted to do the job. But in most situations, the Sponsor has to look inside its own … Continue reading
Posted in Outsourcing Strategy, Vendor oversight
Tagged Execution Risk, Oversight, Quality assurance
2 Comments
What is the “right” outsourcing strategy?
The question of the “right” outsourcing strategy for a given company or project easily reaches the proportions of a religious debate between the fanatical supporters of one approach with equally fanatic opponents. The only fundamental point of view everybody with … Continue reading
Negative GCP inspections (The Neurosearch Case) – does it impact project value?
One of the big challenges in a small biotech company – when starting a clinical research unit from scratch with your first clinical trials – is finding the right balance with your quality assurance system. You have no system established … Continue reading
Sponsor vs CRO – the trial site perspective on the feasibility process
The below recent paper from a clinical trial site sheds some light on the trial site perspective with regard to pharmaceutical company versus CRO relationship. Although this is a very particular example from a specific region in the world – … Continue reading
Posted in Rescue Study Syndrome, Trial feasibility
Tagged Execution Risk, Trial feasibility, Trial Start-Up Tips
3 Comments
Virtuel biotek – den optimale model for en “unbosset” organisation
Lars Kolind og Jacob Bøtter har fornyligt udgivet bogen “Unboss” – som beskriver en bevægelse væk fra traditionel ledelseskultur med hierarkier og faste arbejdstider. Når man arbejder i en lille – og typisk til en vis grad virtuel biotek virksomhed … Continue reading
