Our statistics for 2022-2023
The last year has been very successful for our team. We are grateful that in such challenging times for many businesses, we had the opportunity to set up and manage…
Continue readingclinical trials set up
Bitesize Regulatory News 5 Oct 2021
USA FDA has issued a new draft guideline for safety reporting which is expected to be finalised in Nov 2021. In the new edition they acknowledge that clinical trials are…
Continue readingClinical Trials in Rare Diseases Have Their Rare Problems
Before we can start discussing the issues with conducting clinical trials in rare diseases we can clarify what type of conditions will classify as rare diseases. Often rare diseases include…
Continue readingClinical Trails Imaging Set Up and Requirements
Majority of the clinical trials require images to be performed and often sent to external vendor. These imaging requirements vary between different clinical trials and information about specifications should be…
Continue readingHow to Ship Lab Samples in Clinical Trials?
Majority of the clinical trials use external facilities for lab samples analysis and storage. These facilities are knows as Central lab and they are specific for each region (for example,…
Continue readingCan You Start Clinical Trial Without Local Regulatory Approval?
Often clinical trials teams have country approval and Central Ethics Committee (CEC) approval but they have to wait for their Local Ethics Committee (LEC) approval as well. Some LECs are…
Continue readingClinical Trials Set Up: Budget – Planning Tips
Some hospitals work closely with their financial departments, which support clinical trials budget and contract negotiation, however there are lots of hospitals that do not receive such support. In lots…
Continue readingClinical Trials Set Up: Radiology Team
How many clinical trials teams have good communication with their radiology team? Unfortunately, the answer is: Not many. Oncology is one of the main areas of research and all oncology…
Continue readingClinical Trials Set Up: Pharmacy Team
Although majority of the hospitals have already established contacts and work schedule with their pharmacy team it is still common pharmacy to be involved at later stage and not during…
Continue readingClinical Trials Set Up: Nursing Team
It is common nursing teams not to be very much involved in clinical trials selection and set up. Usually there is 1 or 2 nurses who are supporting the set…
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