We've been sharing you our Insider's Insights with you for 2 years now. We have published nine issues, covering everything from how to write a clinical study report to how to make a professional poster. We hope these have been informative and useful. More issues are on the way, including ones with tips on how to make great slide shows, stay away from copying, and get through the Clinical Trial Application process. Soon, we hope to make several more issues available for download.
Our goal with the current guide is to show you how to best use a ‘concept’ approach during protocol development ensuring that everyone focuses on the study's most important details [1]. It walks you through the basics and gives you tips on how to get everyone on board with the development of a full protocol later.
Few people can simply watch an instructional video or hear something explained and then know the backward and forward of how to do it. Most of us must do something several times to truly learn. In the words of Mr Miyagi (from the 1984 movie classic, The Karate Kid) one of my generation’s leading philosophers, “Wax on, wax off.”
The current guide was written by our Head of Clinical Project Management, Karen Chalk, wrote the guide. She has over 10 years of experience planning and running clinical studies. Karen has overseen our internal quality control system for 5 years, which makes sure we meet all of our regulatory obligations.
The movie (The Karate Kid) provides a great example of how patience, perseverance and delayed gratification are foundational character traits that underpin the achievement of a goal or mastery of a particular skill. Watch the movie but more importantly read the guide. We hope you find it useful and keep it for future reference.
References
Frights create a happy Halloween by providing the thrill of fear in a controlled and safe environment, turning what.
The UK's world-class human challenge study gives us new information about SARS-CoV-2 cases that were mild in 36 healthy.
Investigator-Initiated Clinical Trials (IITs) are clinical studies led by academic researchers or clinicians
Advisory board meetings are often used to address perceived knowledge gaps and build consensus.
Scientific knowledge should be accessible to all and if you are those communicating science
It was encouraging to see so many partners at the 2017 General Assembly meeting last December
Concerns about readiness of the European Medicines Agency’s (EMA) Clinical Trials Information System persist as the.
Searching the literature can take various forms, ranging from a quick scan of recent publications
Finding the best vehicle in which to publish your research findings is a perennial challenge.
Every year, a huge amount of scientific data is released. It's out there, but how do you find it?
Experience at Niche has taught us that clinical study protocols are born in the white-hot fire
The largest pharmaceutical companies not surprisingly rely on the largest contract research organizations
Have you seen our latest Insider's Insight on Case Reports? Once a staple of medical journals,
The proceedings of the Association for Human Pharmacology in the Pharmaceutical Industry (AHPPI)
When I was younger, the opening lines of the Beatle’s seminal ‘Sgt. Pepper’s Lonely Hearts Club Band’ resonated.
I am shamelessly referencing our Insider’s Insights (IIs) to Dr Who’s TARDIS – our latest edition
Did you miss our Insider's Insight into understanding the complex world of bibliometrics [1]?
Rational Vaccines (RVx) announces MHRA Innovation Licensing and Access Pathway (ILAP) approval for their live attenuated.
The clinical stage biotechnology company developing breakthrough therapies for patients suffering with cancer,
We all need heroes - people who can champion our cause - helping the world to understand our rationale
Investigator sites are very important to clinical studies because they make sure that new drugs are safe and work well.
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