One area of patient centricity that might be getting overlooked is patient reimbursement. When patients travel to clinical sites for treatment, how much of their own money are they required to shell out? Are they being promised reimbursement for those expenses? And, if so, how long is it generally taking for them to receive the funds?
An adaptive design is a design that allows for modifications to the processes and statistical procedures of a clinical trial, usually at set intervals established in the trial protocol. Adaptive designs are useful for increasing efficiency and lowering costs associated with clinical research. Studies incorporating adaptive design techniques can be useful in redirecting subject allocation to concentrate on the most promising treatments or in stopping a trial early for futility. The temporal and monetary savings resulting from adaptive designs make them of great value in drug and medical device development.
Many of you have no doubt heard someone in your current or past organization say, “Quality, cost, and speed — pick two.” This statement refers to the perception that a project cannot achieve all three areas as priorities and therefore the organization must choose which two out of the three to prioritize.
Recently a clinical research associate (CRA) candidate I’ll call Evan approached our firm for assistance in finding a new assignment. His resume was impressive, representing strong foundations as a study coordinator with over 10 years of experience as a CRA for highly reputable CROs.
When implementing a randomization and trial supply management (RTSM) system for a clinical trial, there is a shared responsibility between the RTSM vendor and sponsor organizations to ensure the system performs as intended according to predefined requirements.
Trial designs are becoming more complex. Most of these trials are supported by legacy/older technologies that have limited flexibility to quickly adapt to new trial information. The pharmaceutical industry is reaching a tipping point, where the need for flexibility is outweighing the need to be conservative and risk-averse in this highly-regulated environment.
Embrace Agile IRT and realize the benefits that will ultimately accrue to the sites running studies and the patients.
A full-service, highly qualified partner who uses effective technology-enabled financial management services can help ensure efficient site payments, greater transparency into payments on all sides, and satisfied investigators.
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Six steps to choosing an eTMF for your clinical studies.
There are few things more inefficient than a coding specialist manually coding hundreds or thousands of verbatim data entries that have multiple names and spellings for what could have been one standardized term. After searching through all those terms, your specialist then has to code each entry to match the desired term.
When conducting clinical research, the goal is always to achieve the cleanest data possible. If your data is based on undesirable collection methods, messy data entry, or untrustworthy statistical analysis, you are likely to leave many questions unanswered. And vague results won't cut it with the FDA’s rigorous data standards.
Standardization of data collection is happening everywhere you look. For example, when you visit the DMV and apply for a driver’s license, you know the employee didn’t create that form from scratch.
An overview of important eTMF knowledge and insights that were shared at the 2018 TMF Summit.
