Newsletter | February 18, 2019

02.18.19 -- Use eTMF To Navigate FDA Inspections

Featured Editorial
Use eTMF To Navigate FDA Inspections
By Ed Miseta, chief editor, Clinical Leader

“Being inspection-ready means making sure the TMF is up to speed,” says Brent Sorrells, director of clinical operations for Allakos. “During a pre-approval inspection in 2015, we learned quite a few things. The FDA inspector followed the BIMO guidance to a T. One of the primary things I learned is that we were not as organized as we had thought, even though we had done a dry run of an inspection after our NDA filing.”

Industry Insights
Rapid Change, Real Promise: The Future Of Rare Oncology Research
White Paper | By Juliet M. Moritz and Sachin Kulkarni, Premier Research

Insight on the major issues being raised in the rare oncology space today, including patient perspectives on rare cancer research, innovative trial designs, the regulatory landscape, and pending legislation that may impact how studies are conducted.

Industrializing Operational Excellence Through Quality, Innovation, And Expertise
Article | By Jinu Jose, Cenduit LLC

How industrializing operational excellence (OPEX) drives quality patient outcomes and key takeaway as you prepare for 2019 and beyond.

Interactive Response Technology In Clinical Trial Supply
Article | By Dave Holly, Sharp Clinical Services

Interactive response technology (IRT) professionals can bring together supply chain and clinical team staff for discussions on actual trial needs. Learn how including IRT professionals earlier in the planning phase of clinical trials may result in a better understanding of supply chain needs. This can increase the efficiency of inventory management and lead to unforeseen cost savings over the course of the trial.

The Model-Based Approach: A Better Way To Forecast Enrollment
White Paper | Cytel

Compared to conventional approaches, a model-based approach to enrollment forecasting provides a more realistic assessment of the possible risks and outcomes for any given scenario, by accounting for the nonlinearity and randomness of real-life enrollment processes. In addition, a model-based approach offers many more advantages other than more realistic expectations.

Optimizing eConsent For Patient Centricity
Webinar | CRF Health, a CRF Bracket Company

Use of electronic consent can help improve the current paper document approach, but there is more to it than just replacing paper with a multimedia eConsent. What does it take to make eConsent patient-centric?

Detecting, Handling, And Reporting Data Falsification, Misconduct, And/Or Suspected Fraud
Webinar | Rho

Whether indications of fraud appear as missing documentation, altered numbers, signatures that don’t match, or unavailable medical records, clinical research associates (CRAs) must be aware of the many signs of possible fraud or fabricated data occurring at a clinical trial site. This webinar explains the signs to look for and the proper protocol to handle and report the misconduct during each monitoring visit.

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