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.
Six steps to choosing an eTMF for your clinical studies.
eCOA solution provides a truly patient-centric experience for optimal protocol compliance oncology patients an easy solution to use.
Busy and diversified sponsor organization required a data management solution flexible enough to meet the unique requirements of each therapeutic area of study.
Can organizations implement today’s regulatory requirements using conventional approaches?
Software solutions provider adds value for a midsize pharmaceutical company from a quality, cost and study governance perspective by enabling them to implement risk-based (dynamic) approaches to monitoring.
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.
|
|
|
|
|
|
|
|
|