Biocept, Inc. (BIOC)

What Makes an IRT Great for Technology Transfer?

In the last blog we talked about how technology transfer is gaining ground on the conventional Software as a Service (SaaS) IRT sourcing model. In this blog post, I will explain the advantages of the technology and design behind Trident that make it particularly well-suited for IRT technology transfer. So let's dive right in.

Technology Transfer Gaining on Saas

When it comes to Interactive Response Technology (IRT) – systems used to perform subject randomization, drug dispensing and study drug resupply – Software as a Service (SaaS) continues to be the conventional delivery model including here at BioClinica.

Break-out Group Dissects the Development of a Risk-Based Approach To Clinical Trial Management

As SCDM's 2014 Chair I had the honor of presenting the keynote at the EU Leadership Forum held in The Netherlands, December 2014. Celebrating the organization's 20th Anniversary and all that's been accomplished, we took a light-hearted look at the Evolution of the Clinical Data Management Role.

Studies Reveal Impact of Implementing, Standardizing, and Developing Neuroimaging Endpoints in Alzheimer's Disease Trials

Alzheimer's disease is one of the most important health challenges facing aging populations worldwide. Disease modifying therapies are desperately needed and many potential treatments are currently being tested in clinical trials. The role and impact of medical imaging in AD trials continues to grow, especially as clinicians and scientists seek to define and treat AD at the earliest stages of disease.

If you've spent time researching risk-based monitoring (RBM) over the past year, you know dozens of academics, CROs, clinical trial practitioners, and statisticians have proposed varied approaches based on sponsor needs and trial designs. Unfortunately, despite an abundance of theoretical perspectives on RBM, clinical trial teams soon discover a significant gap still exists between perspectives and actual tools to enable real-world RBM implementation.

Intense interest surrounding RBM shows alignment of all the right elements — technology, regulatory bodies and the industry itself – to make risk-based monitoring a reality. If implemented with the right components, this approach could result in the most efficient trial management possible.

Progress on CDISC Standards has come at a quickened pace in recent years. Helping make advancement of industry-wide standards possible is collaboration among CDISC and other participating organizations (Critical Path Institute, Association of Clinical Research Organizations, Innovative Medicines Initiative, and National Cancer Institute). Joining in the collaboration are regulatory authorities and the pharma industry itself, as well as TransCelerate Biopharma which continues to press forward with its standards initiative.

20-Year Retrospective

The role of the Clinical Data Manager (CDM) has changed immensely since 1994, both in terms of role and function. Let's take a fun retrospective look at the great strides made in our field over these last 20 years, and more importantly, where the CDM role is headed. Let's begin with 1994, in honor of the Society of Clinical Data Management (SCDM), which commemorated its 20th Anniversary in 2014.

A recent proposal by the U.S. Department of Health and Human Services (HHS) could expand the amount of clinical trial data that drug companies must share with the public. Under the proposal, clinical trial sponsors would be required to report findings for drugs and devices that fail to reach approval.
 

eSource is a topic that has everyone talking and it continues to dominate the conversation at industry gatherings, including the annual SCDM conference held earlier this fall. From what I heard there − and continue to hear – sponsors' experience with eSource runs the full gamut.

When I speak on the topic of risk-based monitoring (RBM) at industry events, someone invariably comes up afterward to say how nice it is we finally stopped talking about risk-based monitoring!

Dipping a toe in the water is always easier than jumping right into something new.

I am reminded of this old axiom as I look back at the recent SCDM conference and see it holds true for eSource.

Testing different eSource modalities within a controlled environment is one way to get acclimated and explore the use of eSource in your clinical trials while building experience – all in a low-risk way. Beginning with data that's directly entered as eSource is a whole lot easier and safer than attempting to hit it 100 percent from the high dive on the first try.

As I write this, I’m on a return flight home to Philadelphia from Las Vegas where I attended the Annual SCDM conference. It was a great event and I’m pretty revved up to share what I saw and heard there, especially on the evolving topic of eSource.

One session I’d like to tell you about is an eSource roundtable that was moderated by Linda King, Director of Global Data Delivery at Eli Lilly and Demetris Zambas, VP and Global Head, Data Management at Novartis. Representatives from CDISC, Merck, J&J, AssisTek, Quintiles, and Otsuka rounded out the expert panel.

Have you had a chance to read the latest TransCelerate paper on risk-based monitoring (RBM)?

If not, I highly recommend getting your eyes on Technology Considerations to Enable the Risk-Based Monitoring Methodology, published online in August on behalf of the Drug Information Association (DIA). This paper serves as a tremendous resource for any organization interested in new enterprise technology to help realize the advantages of risk-based monitoring.

This summer, experts from academia, industry and regulatory sectors gathered in Reykjavik, Iceland for The International Workshop on Osteoarthritis Imaging (IWOAI) to discuss the latest advances related to imaging in Osteoarthritis (OA). Presentations at this conference centered on new imaging techniques and analytical methods for monitoring OA pathophysiology and evaluating imaging data from clinical studies.