Articles From Our Expert Network
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How To Create An Effective Clinical Supply Visual Dashboard
4/5/2022
It is challenging to keep track of inventory positions at clinical sites, depots, and clinical packaging organizations. Randomization and trial supply management (RTSM) systems do not encapsulate all the necessary data. It is vital to have an internal central inventory system that maintains oversight of the IP inventory from start to finish and to manage resupplies.
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The Current Landscape Of mRNA Vaccines In Clinical Research
3/17/2022
With the Pfizer-BioNTech and Moderna products, mRNA vaccines made global headlines in 2021 in the fight against COVID-19. As we recognize National Immunization Awareness Month, this article shares how mRNA vaccines currently in clinical research and clinical trials may be soon used to fight HIV-1, herpes, cancer, and more.
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FDA Releases Guidance On Digital Health Data Acquisition In Clinical Investigations
3/8/2022
Increasingly, digital health technologies are becoming part of the conduct of clinical trials. They cover a broad range of applications, including ingestible and implantable sensors, wearables, electronic signatures on consent forms, and more. This article summarizes the key takeaways of the FDA's new draft guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. The public comment period ends March 22, 2022.
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The Clinical Trial Sponsor’s Roadmap To Avoid EMA (Cyber) Perdition
3/1/2022
Clinical trials are one of the sectors most vulnerable to cyberattacks. In the European Medicines Agency (EMA)'s Guideline on computerized systems and electronic data in clinical trials, the EMA goes beyond the traditional software validation and data integrity expectations. It sets requirements and expectations pertaining to user management and ongoing security measures.
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Trends In Decentralized Clinical Trial Remote Monitoring For Medication Adherence
2/23/2022
With the implementation of real-time remote monitoring technology, pharmas will be able to do more remote studies that require clinical trial patients to visit sites less frequently. This will remove the burden on patients and improve patient recruitment and retention. This article focuses on the patient medication adherence market.
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Your New 6-Step Approach For CRO Selection In 2022
2/15/2022
Unfortunately, whether you’ve chosen the right clinical research organization (CRO) isn’t always obvious until contracts are signed and patients are enrolled. In 2022, basic industry standard steps are being skipped left and right. Here are 6 win-win suggestions to incorporate into your vendor selection strategy.
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Clinical Trials: FDA Proposes Benefit-Risk Assessment For New Biologics
2/11/2022
The FDA's draft guidance illustrates how a drug’s benefits, risks, and risk management options factor into certain premarket and postmarket regulatory decisions. Communication between the sponsor and the FDA regarding the benefit-risk assessment is typically conducted at the end of the Phase 2 study, which can help influence the design of Phase 3 studies.
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Use Of Wearable And Sensor Applications In Clinical Trials Is Booming
10/26/2021
Experts predict 50% of clinical trials will incorporate wearables and sensors by 2025, compared to the 10 to 15% at present. This article shares market research on the use of wearables and sensors in clinical trials, including smartwatches, ingestible sensor-embedded pills, and more.
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4 Imperatives For Updating Our Clinical Quality Systems Approach For 2022 Pharma
7/29/2021
The clinical quality management systems approach developed 20 years ago is not sustainable in the today’s industry because we've seen dramatic industry changes in outsourcing, remote monitoring, the use of electronic systems in clinical research, and more. But how do we update our approach for 2022 pharma? This article examines 4 imperatives, including how to accomplish them.
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The 6 Pillars Of Effectively Managing Up In Clinical Development
7/22/2021
Managing up, regardless of title, can be a challenging skill to master from the onset. Laurie Halloran and Michelle Pratt of Halloran Consulting share their 6 key lessons that they've learned along their careers in clinical development. This article will help you manage your relationships with your colleagues in a more senior role, while also positioning yourself for success.