Clinical Trial Technology Editorial

  1. Janssen Takes Clinical Supplies And Patient Data From Paper To Digital

    Janssen is seeking to replace paper-based conventional processes of managing clinical supplies and tracking patient health data with a new suite of cohesive digital technologies. The new iSTEP (Integrated Smart Trial & Engagement Platform) is a technology toolset developed to automate investigative product supply and data management in clinical studies.

  2. Wearable Devices: A New Look For The Modern Clinical Trial

    In the last few years there has been significant buzz in the life sciences industry surrounding the use of wearable devices that can be utilized for remote patient monitoring in clinical trials. Many believe wearables have the potential to significantly impact overall trial costs and efficiency, and recently they have returned to the spotlight due to fresh approaches that harness artificial intelligence/machine learning.

  3. Clinical News Roundup: CRS Files Lawsuit Against FDA

    Clinical News Roundup for the week of October 23, 2017 with information on CRS’ lawsuit against the FDA, FDA boosting patient access to medical devices, the Bracket acquisition of mProve, why Alzheimer’s drugs fail, and more.

  4. Three Ways To Improve Quality In Clinical Trial Processes

    Timeliness, cost, and quality are all critical factors that must come together to ensure an efficient and successful clinical trial. Unfortunately, the complexity of trials, combined with coordination challenges, force sponsors to have to identify the opportunities needed to improve trials. But how do you know what efforts will produce the best results?

  5. Use Extension Studies To Enhance Phase 3 Data

    An open-label extension study is one that will lie between a double-blind, randomized controlled drug trial and FDA approval. The primary objective tends to be very different from a typical Phase 3 study, as the focus is on collecting more rigorous information on the long-term safety and tolerability of a new drug. These studies present unique challenges relating to study start-up, contracts, and selection criteria.

  6. Breakthrough Therapy Designation Helps Genentech Navigate Difficult Trials

    FDA started the Breakthrough Therapy Designation program in 2012. Since then, Genentech has garnered 15 designations, more than any other company. Jeffrey Siegel has been an instrumental component of that success. Siegel is Genentech’s senior group medical director and spent 14 years with FDA prior to joining the company. He has spent most of his career in pharma developing products to address the unmet medical needs of patients. 

  7. Clinical News Roundup: Why All The Love For Adaptive Trials?

    Clinical News Roundup for the week of April 10, 2017 with information on Scott Gottlieb and adaptive approaches, preparing for epidemic clinical trials, proposed tax law changes for clinical research, and using selfies to improve medicine adherence.  

  8. Clinical News Roundup: RBM Leads To Cost Savings

    Clinical news roundup for the week of April 1, 2017 with information on RBM and cost savings, a culture change around clinical data, proposed clinical research tax credits, increasing patient diversity, the pharma industry in Mexico, and patient trust and satisfaction.

  9. The Science Of M&A: Making The Most Of Your Financial Resources

    As CEO for France-based biotech Onxeo, CEO Judith Greciet is always looking for new opportunities to bring complementary products on board to expand her company’s pipeline. Onxeo currently has three compounds in clinical development, with one at the end of its Phase 3 trial. “External development is a key path in our strategy to grow the company,” says Greciet. “Whether you refer to this as an acquisition or inlicensing, we knew we would require additional, innovative assets to widen our pipeline and increase the value of the company.”

  10. Patient Survey: Technology Use Up, Pharma Disconnect Remains

    The patient advocacy firm Inspire has released the results of its second annual Insights From Engaged Patients survey. Over the last two years, Inspire has captured insights from nearly 24,000 patients and caregivers who face multiple health conditions. The survey looked into several areas related to patient interactions with social media, physicians, and most importantly, pharma companies.