Newsletter | February 10, 2020

02.10.20 -- Stem Cell Therapy Trial Offers Hope To Osteoarthritis Patients

  Webinar: 2019 Year In Review

ISR is a market research firm operating exclusively in the pharmaceutical manufacturing and clinical research space. In 2019 they conducted approximately two dozen individual pieces of market research for syndication. This webinar will summarize many of the important learnings from these projects, providing attendees with real, usable data for 2020 activities.

Featured Editorial
Stem Cell Therapy Trial Offers Hope To Osteoarthritis Patients
By Ed Miseta, chief editor, Clinical Leader

Cynata Therapeutics is producing products called mesenchymal stem cells (MSCs), which have huge therapeutic potential for numerous unmet medical needs. The company’s Cymerus technology addresses many of the challenges and complexities of manufacturing stem cells at commercial scale.

Overcome The Challenges Of A Clinical Technology Implementation

New technologies can offer many benefits to a clinical operations department. Those benefits can include faster, more efficient, and less costly trials. Still, the risk-averse nature of many pharma companies can make them reluctant to adopt new technologies. In November 2019, Lawrence Florin, president of LBF Biopharma Consulting, provided actionable information on how to overcome the hurdles of acquiring a new technology.

Industry Insights
Ticking Boxes: Immuno-Oncology Trials Checklist
Article | By Elizabeth Koury and Jeff Mayhew, LabConnect

Because of its promising outcomes, immuno-oncology is a significant and growing segment of clinical research, but one that does not come without challenges. Following the guidelines for best practices within immuno-oncology trials can be made easier by following this comprehensive checklist.

Top Trends In Oncology Patient Support
Article | By Jennifer Lichtman, United BioSource LLC (UBC)
Patient support services must continue to evolve and flex as the oncology market transforms. Here are five trends to consider in the future for successful support of patients with cancer.
Why Site Collaboration Is Key To Abating The “One And Done” Syndrome
Article | By Jae Chung, Oracle Health Sciences

Sites opting out of future studies because the burden of participating is too great, commonly known as the “one and done” syndrome, is plaguing the industry and delaying drug development. Learn how unified platforms, change management practices, and site networks could be part of the solution.

Clinical Trial Transparency Policy Reference Guide
White Paper | TrialScope

A transparency policy can go a long way toward building trust and enhancing a company’s brand reputation. Discover six commitments related to disclosure and data sharing that a solid transparency policy should include.

What Level Of Review Does Your Study Need?
White Paper | Advarra

The level of IRB (institutional review board) review required for research involving human subjects depends on the study’s specific design and the risks involved. Some research must be reviewed by the fully convened IRB, while others may be reviewed by a designated IRB member. Some projects may not even require IRB review. By applying the same four-step evaluation process used by IRB members, research professionals can better plan for a study’s necessary level of review and save time in study start-up.

A Guide To Evaluating eRegulatory Software For Clinical Research Sites
White Paper | Veeva Systems, Inc.

Researching eRegulatory management software for your investigative site? Start with this easy-to-follow buyer's handbook on the most important features to consider.

Reasons For Building An Approved Phrase Library
E-Book | Thermo Fisher Scientific

The challenge of creating labels for investigational drugs is mounting as more countries sign on to participate in clinical trials. Delays in translating and approving clinical labels can prevent clinical trials from starting on time and threaten to derail development timelines. This e-book discusses the challenges of translating and approving label text and how an approved phrase library can reduce label timelines, improve quality, and assure regulatory compliance.


How many companies are actually making their trials more patient-centric? Join Clinical Leader Live on Wednesday, February 12, 2020, for a virtual conference examining what “patient-centricity” means from three perspectives: sponsors, patients, and advocacy groups.

myTI: Mobile eTMF
Reduce Cost And Effort When Servicing Clinical Trials In Canada
Ropack Pharma Solutions
Clinical Trial Packaging
Bellwyck Pharma Services
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