Advertisment
|
|
news roundup
U.S.-based CRO Novum Pharmaceutical Research Services has selected TrialMaster electronic data capture (EDC) technology from OmniComm Systems, Inc. to its more than 200 research studies it conducts annually.
| advertisment
Tomorrow's Clinical Trial, Powered by Modern EDC
See how to cut study build time in half, eliminate migrations, and remove the need for source data verification (SDV).
 See a preview and watch the full webinar here. |
Clinerion has added HL7's FHIR data exchange standard into its Patient Recruitment System platform to process electronic medical records more efficiently. Hospitals using FHIR may now directly exchange data with the Patient Recruitment System without the need for additional implementation.
| |
|
| advertisment
ERT Video Series
Check out the ERT video series, filmed on the show floor at DIA 2017, for interviews on Innovating Clinical Trial Management, eCOA in Clinical Research: Trends and Advances, and Optimizing Clinical Trial Imaging through Advanced Technology.
 Click here to watch all 10 short videos |
Subscribe
 |
Stay connected with Applied Clinical Trials and sign up for your print or digital issues, as well as our enewsletters.
Subscription offers » |
|
|
|
Advertisment
|
|
| advertisment
Rare disease trials differ from those in most other therapeutic areas because the indications are more complex and involve smaller patient populations. In a series of white papers, PRA experts discuss the barriers drug developers face when positioning a new trial in the rare disease space and how to minimize these while engaging with the right patients.
 Read more |
As the voting deadline for the new EMA location is scheduled for November 20, tensions across various stakeholders are mounting. From patient groups, to current EMA employees, to officials in the cities in the running, a stream of concerns and issues are coming out of the EU.
| advertisment
Future-proofing your Pharmacovigilance Delivery Model: Achieving scalability and cost effectiveness with AI/smart machines
Live Webinar: Wednesday, October 25 at 11:00am EDT
 Register now |
Read the latest people moves, company recognitions and more.
|
|
|
| advertisment
Navigating the Regulatory Complexities of Orphan Drugs: Know the unwritten rules of designations and what's next
Live Webinar: Thursday, November 2 at 11:00am EDT
 Register now |
| advertisment
Rare Diseases and the Eye - Envisioning Strategies for Success
Live Webcast: Friday, October 27 at 11:00am EDT
 Register now |
|
Advertisment
|
|
Articles
Consultants from ZS Associates offer how to implement the four pillars to achieving patient centricity: Understanding patients; meeting patients' needs; connecting patients; and engaging patients.
| advertisment
RBM Technology Impact on Clinical Roles: Centralized Monitoring is streamlining activities and changing roles across clinical development
On Demand
 Learn more |
This article discusses mitigating risk during the transportation process, when a drug product is exposed to a range of temperature fluctuations, leading to excursions that could impact its stability, making the treatment unfit for patient administration.
|
|
|
Blog Posts
At the first meeting of FDA's Patient Engagement Advisory Committee (PEAC), the panel discussed how requirements for informed consent, randomization, and study duration affect enrollment and participant retention in clinical trials, and what methods might be most effective for recruiting diverse patient populations.
| advertisment
Proactive Planning, a Transformational Revolution to Improving Clinical Trial Quality?
On Demand
 Learn more |
Time has shown that central review of multicenter research has important advantages over re-review at local IRBs and patients are frequently cited as stating that minimizing the time and administrative burden to enrolling in clinical trials is very important to them.
|
|
|
Risk-Based Monitoring
In this upcoming session at the Risk-Based Trial Management and Monitoring event on November 2 and 3, attendees will hear directly about the impacts on sites, sponsors and CROs when implementing RBM. This panel discussion will discuss how these groups effectively communicate with one another and the challenges they face with RBM implementation.
There was no clear opinion whether RBM facilitates the work of a CRA, neither in 2014 nor in 2016, but overall only half of the CRAs experience the RBM model as a supportive tool. The survey performed in 2016 reveals a persisting preference to traditional monitoring and skepticism about the ability to maintain high data quality with RBM.
|
|
|
This peer-review article explores a research project developed by two pharma-related companies and two academic institutions initiated in 2014 to develop a holistic system via process integration to effectively control clinical trial risks beyond isolated RBM strategies.
|
|
|
|
|
Read the digital edition of Applied Clinical Trials
Click here to sign up or renew your subscription |
|
|
|
|
|
