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What's the Role of a Data Manager in a Risk-Based Model?

  • 0
  • 17 Oct

Risk-based monitoring (RBM) is finally starting to gain momentum as the standard for trial execution within the industry. In fact, a few of the Transcelerate companies are already working in a model where RBM is deployed across all trials, and RBM is also finally starting to take off with mid-size to small pharma. Before long, RBM will become the de facto standard for trial execution. Because on-site monitoring practices were the first to change in the move toward an RBM-based strategy, the initial impact has been absorbed by clinical operations teams.

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8 Essential Imaging Strategies to Revolutionize Your Clinical Study

  • 0
  • 16 Oct

Imaging is utilized in clinical trials across most therapeutic areas and is leveraged to monitor safety, assess efficacy, and provide primary, secondary or exploratory endpoints. The challenge imaging has faced ever since it's been incorporated into clinical trials is that it has succumbed to being "the forgotten one". Many times the preparation and conduct of imaging is an afterthought in clinical trials and for whatever reason is thought to be an easy part of the study design, implementation and execution. Nothing could be further from the truth.

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Webinar Q&A Follow Up: How Innovations in Data Visualization Are Accelerating Data Cleaning and Improving Quality

  • 0
  • 12 Oct

On September 18, I presented a webinar entitled "How Innovations in Data Visualization Are Accelerating Data Cleaning and Improving Quality," during which I discussed the importance of database (DB) lock as a trial milestone. A key step towards DB lock is tracking all activities are completed and clean for each patient (coding, external data reconciliation, query status, etc.), which can often be a challenge particularly for studies with large amounts of data.

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Gain Payment Transparency and Visibility With ClinViz

  • 0
  • 10 Oct

Site satisfaction is recognized as an important factor for adherence to trial timelines and budget costs. And, sites report getting paid on time as a top-ranked concern, with one-third of North American sites waiting at least 90 days for payments. Slow payments cause financial stress for most sites and can result in high site turnover, while on-time payments motivate sites to drive data quality results and optimize site performance.

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Upcoming Cardiac Safety Webinar Series

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  • 25 Sep

Join Bioclinica's Cardiovascular Safety experts this October for a 3-part webinar series as they review recent advancements and direction in the evaluation of cardiac safety and efficacy in drug development. Through use of case studies, presenters will share insights focused on the recent ICH E14 Q&A, application of cardiovascular imaging in drug safety monitoring and electronic clinical event adjudication.

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To Thorough QT or Not to Thorough QT – That is the question

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  • 21 Sep

Thanks to scientific advancements and increased understanding of pathways and systems that contribute to cardiac risk, the cardiac safety ECG environment continues to mature and expand. Presently, the assessment of QT/QTc from the electrocardiogram is the primary focal endpoint in cardiac safety.

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Upcoming Webinar: Clinical Payments Case Studies: Improving Efficiency, Cash Management, and Compliance

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  • 19 Sep

Join us for our upcoming webinar on September 26th during which Bioclinica expert, Lorie McClain, Vice President of Product Management, Product Development & Technology, will present and discuss case studies providing insight into how improvements in clinical payments can make your clinical trials more efficient, while improving your cash management and compliance.

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Optimizing the Approach to IRT Customization

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  • 07 Sep

The clinical randomization and supply chain management systems we now dub “IRT” were initially built as fully customized IT projects, individualized and implemented separately for each study. While the processes have improved since then and some IRT providers are now using systems designed for more configurability, the mindset of customizing IRT systems for each study persists.

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Upcoming Webinar: How Innovations in Data Visualization Are Accelerating Data Cleaning and Improving Quality

  • 0
  • 05 Sep

Join us for our upcoming webinar on September 18th during which Karen McPoyle, Director of Data Strategy & Solutions at Bioclinica, Inc., will present and discuss the importance of ensuring completed and clean activities for each patient, to achieve a successful and timely database (DB) lock.

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Congressman Patrick Meehan Visits Bioclinica

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  • 31 Aug

Bioclinica was honored to host Congressman Patrick Meehan representing the 7th Congressional District in Pennsylvania in a visit to our Audubon, Pennsylvania offices on August 28. Congressman Meehan met with Bioclinica senior leadership, including our CEO Dr. John Hubbard...

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Four Steps to Creating a Roadmap to ICH E6 R2 Compliance

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  • 29 Aug

Since the release of ICH E6 R2 in November 2016, we have been flooded with opportunities to attend and view webinars, seminars and blogs on the topic. While extremely educational, these industry-led learning sessions rarely provide sponsors or CROs with what you so desperately need… a practical guide to creating a roadmap to compliance. While Regulatory Affairs (RA) and Quality Assurance (QA) departments have likely read these new guidelines, holistic organizational education and awareness of their impact and how they affect the way in which we execute trials are still lacking.

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Upcoming Webinar: IRT Best Practices: How Companies Are Accelerating Timelines While Improving Quality

  • 0
  • 23 Aug

Join us for our upcoming webinar on September 13th during which Bioclinica experts Senior Director of RTSM Operations and Commercial Solutions, and Robin Barber, Manager of RTSM Solutions Engineering, will present and discuss case studies providing insight into how to improve quality and reduce risk while accelerating timelines using agile methodologies.

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Pages

What's the Role of a Data Manager in a Risk-Based Model?

  • 0
  • 17 Oct

Risk-based monitoring (RBM) is finally starting to gain momentum as the standard for trial execution within the industry. In fact, a few of the Transcelerate companies are already working in a model where RBM is deployed across all trials, and RBM is also finally starting to take off with mid-size to small pharma. Before long, RBM will become the de facto standard for trial execution. Because on-site monitoring practices were the first to change in the move toward an RBM-based strategy, the initial impact has been absorbed by clinical operations teams.

Read More

8 Essential Imaging Strategies to Revolutionize Your Clinical Study

  • 0
  • 16 Oct

Imaging is utilized in clinical trials across most therapeutic areas and is leveraged to monitor safety, assess efficacy, and provide primary, secondary or exploratory endpoints. The challenge imaging has faced ever since it's been incorporated into clinical trials is that it has succumbed to being "the forgotten one". Many times the preparation and conduct of imaging is an afterthought in clinical trials and for whatever reason is thought to be an easy part of the study design, implementation and execution. Nothing could be further from the truth.

Read More

Webinar Q&A Follow Up: How Innovations in Data Visualization Are Accelerating Data Cleaning and Improving Quality

  • 0
  • 12 Oct

On September 18, I presented a webinar entitled "How Innovations in Data Visualization Are Accelerating Data Cleaning and Improving Quality," during which I discussed the importance of database (DB) lock as a trial milestone. A key step towards DB lock is tracking all activities are completed and clean for each patient (coding, external data reconciliation, query status, etc.), which can often be a challenge particularly for studies with large amounts of data.

Read More

Gain Payment Transparency and Visibility With ClinViz

  • 0
  • 10 Oct

Site satisfaction is recognized as an important factor for adherence to trial timelines and budget costs. And, sites report getting paid on time as a top-ranked concern, with one-third of North American sites waiting at least 90 days for payments. Slow payments cause financial stress for most sites and can result in high site turnover, while on-time payments motivate sites to drive data quality results and optimize site performance.

Read More

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Bioclinica is organized into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging & Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Molecular Marker Laboratory. Our eHealth segment comprises eClinical Solutions, Randomization & Trial Supply Management, Safety & Regulatory Solutions, and Financial Lifecycle Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

RT @bioclinica: Attending CBI's IRT conf? Catch 10/27 @bioclinica GSK talk on bens of sponsor controlled #IRT. Here's the core tech https:…
bioclinica (3 days ago)
RT @Xtalks: Clinical Event Adjudication: Comprehensive and Efficient Dossier Review Using a Global On-Line Solution @bioclinica https://t.c…
bioclinica (3 days ago)
RT @eClinical_Jen: Good Morning from NJ! @bioclinica is a sponsor of the clinical supply show because we have awesome supply forcasting and…
bioclinica (4 days ago)
Attending CBI's IRT conf? Catch 10/27 @bioclinica GSK talk on bens of sponsor controlled #IRT. Here's the core tech… https://t.co/zFiQswIQFb
bioclinica (5 days ago)
RT @Xtalks: #Cardiovascular Imaging for Monitoring Safety: Visualizing Outcomes @bioclinica https://t.co/5osqBkDFKm
bioclinica (5 days ago)
Want stellar imaging acquisition & assessment in your #clinicaltrial ? Get tips in @bioclinica 's Tim Crowe's blog https://t.co/hzbV3Cmlyc
bioclinica (6 days ago)

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