Newsletter | June 7, 2021

06.07.21 -- What You Must Know About APAC Before Deploying Your Next Clinical Trial

Featured Editorial
Industry Insights
Setting A Strong Foundation For Your Oral Solid Dose Product To Support Late-Stage Development

Drug sponsors face significant pressure to reduce the time required to move a new molecule through Phase 1 and into Phase 2 trials. If all goes well, identifying the quickest scale-up path for supplying efficacy trials and commercial demands is next, while keeping the formulation as simple as possible.

The Fight Against COVID-19 Needs The Real-World Data Now Available To Researchers Worldwide

With the resurgent spread of COVID-19 through American communities nationwide comes an explosion of COVID-19 data as a byproduct — real-world data (RWD) necessary and useful to accelerate containment, tracing, and treatment solutions. But to access the intelligence within the data, our industry must step up in the proliferation of innovative data-driven solutions.

Recipe For Success In Radiopharmaceutical Studies

Radiopharmaceutical (RP) studies are not your average clinical trials. With the RP space expanding, sponsors need a team with the experience it takes to turn their synopsis into a fully rounded protocol with the maximum chance of success.

Five Easy Investigator Payment Fixes To Improve Site Relations

Site satisfaction is closely linked to the frequency, accuracy, and timeliness of clinical trial payments. Yet, making payments has long been a challenging process between sponsors and sites. This white paper reviews five common issues that delay site payments and offers recommendations to resolve these issues, improving payment efficiencies and, ultimately, site satisfaction.

Insights Into The Competitive Clinical Manufacturing Market

There are perhaps too many options when it comes to choosing the right service provider for clinical manufacturing. Drug innovators weigh in on their selection metrics and preferences and also reveal why vendors lose bids.

AI-Assisted Indexing Improves Trial Master File (TMF) Management

The timely and accurate filing and indexing of documents for the trial master file (TMF) is one of the most significant compliance challenges facing organizations today. In this case study, you can learn how Phlexglobal’s advanced machine learning technologies reduced a pharmaceutical company’s document processing time by 16% while maintaining 98% accuracy.

Clinical Data Capture: Enhancing Conventional Methods With Continuous Digital Measures

As the capabilities of wearable technologies continue to advance and the decentralization of clinical trials has become a mission-critical objective for many sponsor organizations, conventional methods of data collection must evolve to meet this changing industry landscape. Clinical trial sponsors have an incredible opportunity to increase the precision, quality, and completeness of clinical data by augmenting subjective patient reports and point-in-time clinical outcome data with continuous digital measures. In this e-book, we discuss several conventional data capture methodologies and ways in which objective, real-world actigraphy data can enhance or, in some cases, even replace these traditional assessments.

Implications Of Historical Studies For Rare Disease Products

Development programs in rare diseases are becoming more common and a major focus for small biotech and pharmaceutical companies. A crucial consideration in clinical study and protocol design in these indications is the choice of the control group used to assess the efficacy of an intervention.

Challenges Of Drug Development In L-dopa-Naive Subjects With Diagnosis Of Early Parkinson's Disease

Tomislav Babic, M.D., Ph.D., vice president of neuroscience at Worldwide Clinical Trials, discusses the potential benefit of a delay in initiation for symptomatic treatment with levodopa in early Parkinson's disease patients.

Site-Centric Clinical Platforms Are Better For Sponsors

Site-centric clinical platforms deliver greater operational efficiencies and accelerated timelines across clinical trials. Discover how seven of the top 15 global biopharmaceutical companies came together on a single clinical technology platform and operate through common workflows and leverage common trial documents. In turn, find out how this environment helps sites and investigators stay at the center of this ecosystem.


Virtual  |  July 27 - July 1, 2021

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