CBI Scene Blog

Direct-to-Patient, Remote Trials, Site-less Trials, and Digital Trials Different Ways of Saying 'Trial Success' and 'Positive Patient Experiences'

Posted by Evanna Payen on Jul 16, 2018 10:50:58 AM

CBI’s Direct-to-Patient Clinical Trials conference will address all these leading groundbreaking trials and help you keep pace with a rapidly changing frontier regardless of what terminology you utilize. For a quick look at how site-less, remote, digital, and direct-to-patient trials cover the same ground check out the trial definitions from industry leaders below.

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Topics: Clinical

Q&A with Matthew Amsden, Founder and CEO of ProofPilot

Posted by Evanna Payen on Jun 25, 2018 1:03:06 PM

It's Gay Pride Month and events across the world celebrate wins and bring attention to issues that still need attention. The community still struggles with health disparities and the HIV epidemic. CBI Conference Producer, Trevor Sosvielle, sat down with Matthew Amsden, CEO of ProofPilot to chat about his early work in HIV prevention trials. He tells explains how these experiences helped shape ProofPilot and its patient-centric clinical trial approach.

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Topics: Clinical

How to Align Management with Functional Areas of R&D

Posted by Evanna Payen on Apr 11, 2018 9:39:01 AM

While it's an issue that's not limited to the pharmaceutical industry, miscommunication between the "doers" - those actually performing clinical trials - and the "planners," who set and monitor the budget, is particularly prominent. While research and development in a non-pharmaceutical business can often be put on indefinite hold while funding is secured, clinical trials don't share that luxury. Variables such as timing, resources, and the ability to make adjustments if obstacles arise are freedoms all crucial to a given trial's success. This means, in turn, that "holding" isn't really a viable option. So how can the behind-the-scenes program teams work in tandem with those on the front lines?

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Topics: Clinical, Finance, Compliance

How to Know You’re Keeping Your (Clinical Trial Supplies) Cool

Posted by Colette Thorold on Oct 11, 2017 9:26:10 AM


Today, nearly 40 percent of all healthcare products are temperature sensitive (1). It is expected that eight of the top ten global biopharmaceutical products will require cold chain handling by 2020 (2). These sensitive products must be stored within a limited temperature range until their expiration dates to ensure they retain their effectiveness. Furthermore, many products, including those stored at room temperature (from 15°C to 25°C/60°F to 75°F), may require temperature monitoring as well, driven by stricter regulatory guidelines.

Traditional methods for shipment temperature monitoring involve USB or similar loggers which require the site staff to plug in the USB, download the PDF, upload or manually enter into the RTSM (Randomization and Trial Supply Management), also known as IRT (Interactive Response Technology) system. Site users must then email the CRA before the kit/shipment can be marked as damaged/quarantined/available. Multiple issues arise from this approach:

      • Time spent on manual logger processing could mean less time for site staff to spend with patients
      • Sponsors are finding site enrolment is increasingly competitive and sites prefer sponsors who “make their lives easier” by improving the arrivals process
      • Lack of visibility of temperature excursions means less assurance of safety of medication
      • Multiple temperature monitoring options (loggers, fridges etc.) and lack of integration between them causes delays and data errors
      • The temperature logging often ends upon shipment arrival, leaving gaps in monitoring (this is often due to the logger being associated to a complete shipment not an individual pack/kit)
      • Shipments/packs can be quarantined for a long time due to uncertainty around safety and the length of time to investigate the temperature excursion(s)
      • It is only upon arrival at site that excursions are discovered, increasing the risk that a patient attends a visit and cannot receive medication due to quarantine

It's difficult to get an aggregated view of temperature data throughout the entire ‘supply chain of custody’ – from the point of packaging to dispensation to the patient. Applying Mobile and Cloud Technologies to Temperature Management and RTSM Integration Read More

Topics: Clinical

The Changing Role of the CRA in an RBM World

Posted by Anushka Paul on Apr 5, 2016 4:05:50 PM

Approximately a third of clinical trials conducted utilize some elements of Risk Based Monitoring (RBM), with this figure expected to increase. Site monitoring has been identified as one of the largest components of clinical trial expenditure. With the change in the way that site monitoring is performed, the role of the Clinical Research Associate (CRA) is significantly changing.

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Topics: Clinical

Q&A With Executive Director of the Center for Lawful Access and Abuse Deterrence (CLAAD) on the Challenges and Future of ADFs

Posted by Sabrina Delio on Mar 8, 2016 10:46:19 AM

We recently had an opportunity to speak with Michael C. Barnes, Executive Director of CLAAD, about some of the obstacles and future trends that Life Sciences ADF drug manufacturers are facing today. Read his answers and begin to prepare for the FDA led discussions at CBI's Abuse-Deterrent Formulations Summit in March.

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Topics: Clinical, Compliance

Inside Secrets: The Future of Abuse Deterrent Formulations

Posted by Daria Binder on Apr 30, 2015 11:10:16 AM

With increased pressure on the pharmaceutical industry to come up with creative solutions for the growing drug abuse epidemic in America and a new FDA legislation in effect, the time is now for bio/pharma manufacturers to analyze their formulations and ensure that new and existing products are meeting regulatory standards, reducing misuse potential and minimizing abuse liability. It is critical that the industry adapts quickly in order to ensure their drugs adhere to pre-marketing and post-marketing study requirements, as well as labeling mandates for improving drug safety and achieving market access.

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Topics: Clinical, Compliance

5 Initiatives to Advance Research into Rare Disease Therapies

Posted by Linda K on Aug 28, 2014 11:45:00 AM

Rare diseases have traditionally received far less attention from legislators, researchers and pharmaceutical companies than more prevalent health issues. Rare diseases have often been overlooked because of a myraid of reasons including: lack of research on the disease state, difficulty in finding and retaining patients to participate in clinical trials, getting coverage approvals from payers, spreading market awareness about the disroder, and the financial return of such therapies.

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Topics: Patient Access, Clinical

INFOGRAPHIC: The Evolution of Clinical Technology

Posted by Logan Fleck on Aug 4, 2014 4:04:21 PM

Individuals and businesses worldwide are enlisting technology to expedite their daily tasks, and clinical trial researchers are no exception. But significant improvement to eClinical Technology have been accompanied by a new set of challenges. Learn how the transition from manual to digital processes is transforming your industry.
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Topics: Clinical

Requirements for Open Payments Reporting for Clinical Research

Posted by Miranda B on Jun 19, 2014 10:00:00 AM

According to the Centers for Medicare and Medicaid Services, there has been a final ruling on the National Physician Payment Transparency Program: Open Payments, better known as the Sunshine Act. Under the Open Payments program, data collection of medical device and drug manufacturers who send gifts and payments to physicians and teaching hospitals is now mandatory. This applies to any manufacturer who receives government reimbursement, and collection data will be posted on a public website as of September 30, 2014.

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Topics: Clinical, Compliance