|
|
|
International Clinical Trials
|
Clinical trials require the management of more data than ever before, but many of the tools available on the market have prodigious shortcomings in both this and safety. Sponsors and CROs struggle to collect, synthesise and analyse information from myriad siloed sources, which affects their understanding of drug safety and slows data reconciliation for submission. An alternative approach to data integration could power the next generation of clinical innovation by bridging the functional and structural gaps between information management and pharmacovigilance (PV).
Regulatory agencies are concerned about trial data quality and patient safety. The recent emphasis on risk management in the latest ICH E6 (R2) guidelines makes it clear that there is significant work to do in removing the barriers to data review, quality oversight and safety monitoring. Both sponsors and CROs rely on an increasing number of systems and datasets to manage complex and often decentralised clinical studies. Their data are often siloed, which makes obtaining a holistic picture of the trial challenging.
Most data management solutions on the market today are inflexible and fall short in their ability to power the solutions needed to best manage clinical research, particularly as they pertain to timely interfaces with PV. All PV systems will ultimately provide information in the E2B format as required, but data structures from clinical data management systems (CDMS) vary, and conversion to study data tabulation models or other formats can delay key deliverables for holistic study risk and safety management.
|
Read full article from PDF >>
|
|
 |
|
| Rate this article |
You must be a member of the site to make a vote. |
|
Average rating: |
0 |
| | | | | |
|
|
 |
News and Press Releases |
 |
PCI Pharma Services Announces Bottling Line Expansion to Support Customer Needs
Philadelphia, USA – February 5, 2019 PCI Pharma Services (PCI), a full-service provider of specialist outsourced drug manufacturing, clinical trial services, and commercial packaging to the global biopharmaceutical industry, is pleased to announce the expansion of its bottling line capacity at its Commercial Packaging site in Rockford, IL. Construction of the additional packaging suites began in March 2018 to add considerable footprint for primary and secondary packaging operations equipped with high speed tablet filling, cartoning, as well as in-line serialization and aggregation in support of increased customer demand. The new expansion will grow the robust bottling operation in Rockford by producing an extra 100 million bottles per year.
More info >> |
|
 |
White Papers |
 |
|
Running Smarter Trials With Data-Driven Monitoring
PAREXEL
Clinical monitoring remains one of the most important and most costly activities in the clinical research paradigm. Monitoring provides the operational transparency required by investigators, sponsors, and regulators to make informed decisions about site performance, patient safety, and overall study progress. Yet unlike many clinical trial activities, which have been steadily transformed by technology, the monitoring function itself has changed little.
More info >> |
|
 |
Industry Events |
 |
Clinical Trial Supply Global Forum
20-22 May 2019, Brussels, Belgium
You can’t get a drug to market without a clinical trial. You can’t run a clinical trial without product supply.
We understand that your role is critical in ensuring the on time and efficient development of the next life saving drug and we know that this makes your time precious.
In 2019 we have condensed everything you need to advance your Clinical Trial Supply into three jam packed days.
The industry's most interactive and solution focused CTS forum features deep dive workshops, live polls, panel debates, round table discussions and exclusive key note case studies to ensure that you leave with the industry's best solutions and strategies to transform your clinical trial supply.
If there is ONE Clinical Trial Supply conference that you attend in 2019, make sure that it is this one.
More info >> |
|
|
