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Removing Risk from Clinical Trial Management System (CTMS) Implementations

Upcoming Webinar: Removing Risk from Clinical Trial Management System (CTMS) Implementations

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  • 15 Nov

Join us for our upcoming webinar on November 28th during which Justin Hunt, Director of CTMS Implementation Services at Bioclinica, Inc., will present and discuss a case study providing insight into the benefits realized by a contract research organization (CRO) purchasing a CTMS who started with a small, limited implementation.

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Collaboration Between Clinical Operations and the Logistics and Supply Chain Teams is Key to Trial Success

Collaboration Between Clinical Operations and the Logistics and Supply Chain Teams is Key to Trial Success

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  • 13 Nov

The need to collaborate with internal and external teams for a trial to be successful isn’t a new idea or concept. However, we still see the detrimental effects of a lack of communication between organizational teams; this is particularly true when the clinical operations team fails to communicate with the supply chain and logistics team about upcoming changes. Understanding how decisions made by one group ultimately impacts other groups is important for conducting a successful clinical trial.  

Let’s use a global trial with sites in Brazil as an example.

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The Value of Protocol Review

The Value of Protocol Review

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  • 08 Nov

One of our strategic customers recently invited me to review a draft protocol synopsis for a pivotal Phase III registration study. As the provider of the randomization and trial supply management (RTSM) solution  for the study, I relished the opportunity. Having reviewed thousands of protocols throughout my career, I knew that this was an ideal opportunity to consult with the clinical team to refine and optimize critical aspects of the study design.

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CTMS and RBM: Hot Topics at OCT Nordics in Copenhagen

CTMS and RBM: Hot Topics at OCT Nordics in Copenhagen

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  • 24 Oct

The 5th Annual Outsourcing in Clinical Trials (OCT) Nordics conference provided another outstanding opportunity to explore a beautiful city, stay in the world’s greenest hotel and gain additional insight into aspects of clinical trials that are important for my daily work and even those that don’t touch my daily eClinical life. The mix of representatives from long-established pharma, CROs, biotech and third-party vendors enabled refreshing conversations about how we can work together to improve our communication and move in synergy toward our shared goals.

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

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  • 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

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  • 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

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  • 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

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  • 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

By Anonymous (not verified)
  • 0
  • 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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Removing Risk from Clinical Trial Management System (CTMS) Implementations

Upcoming Webinar: Removing Risk from Clinical Trial Management System (CTMS) Implementations

  • 0
  • 15 Nov

Join us for our upcoming webinar on November 28th during which Justin Hunt, Director of CTMS Implementation Services at Bioclinica, Inc., will present and discuss a case study providing insight into the benefits realized by a contract research organization (CRO) purchasing a CTMS who started with a small, limited implementation.

Read More
Collaboration Between Clinical Operations and the Logistics and Supply Chain Teams is Key to Trial Success

Collaboration Between Clinical Operations and the Logistics and Supply Chain Teams is Key to Trial Success

  • 0
  • 13 Nov

The need to collaborate with internal and external teams for a trial to be successful isn’t a new idea or concept. However, we still see the detrimental effects of a lack of communication between organizational teams; this is particularly true when the clinical operations team fails to communicate with the supply chain and logistics team about upcoming changes. Understanding how decisions made by one group ultimately impacts other groups is important for conducting a successful clinical trial.  

Let’s use a global trial with sites in Brazil as an example.

Read More
The Value of Protocol Review

The Value of Protocol Review

  • 0
  • 08 Nov

One of our strategic customers recently invited me to review a draft protocol synopsis for a pivotal Phase III registration study. As the provider of the randomization and trial supply management (RTSM) solution  for the study, I relished the opportunity. Having reviewed thousands of protocols throughout my career, I knew that this was an ideal opportunity to consult with the clinical team to refine and optimize critical aspects of the study design.

Read More
CTMS and RBM: Hot Topics at OCT Nordics in Copenhagen

CTMS and RBM: Hot Topics at OCT Nordics in Copenhagen

  • 0
  • 24 Oct

The 5th Annual Outsourcing in Clinical Trials (OCT) Nordics conference provided another outstanding opportunity to explore a beautiful city, stay in the world’s greenest hotel and gain additional insight into aspects of clinical trials that are important for my daily work and even those that don’t touch my daily eClinical life. The mix of representatives from long-established pharma, CROs, biotech and third-party vendors enabled refreshing conversations about how we can work together to improve our communication and move in synergy toward our shared goals.

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.

What's next from Bioclinica? Hear if first during #PCTrials Europe next week in Amsterdam! https://t.co/ICngaxA9mg https://t.co/SXxPj3NpD2
bioclinica (3 hours ago)
Join Bioclinica's Justin Hunt on Nov. 28 in a live webinar! Find out how to overcome common hurdles in CTMS impleme… https://t.co/wHfWHtI7sj
bioclinica (Yesterday)
Another CRO seeing big gains in the sites payments process! Access the Case Study here https://t.co/jsCxhmKcLo https://t.co/LpIKEtBKtE
bioclinica (Yesterday)
Great advice from our Dir. Cardiovascular Imaging on quality imaging acquisitions & assessments in clin trials. https://t.co/OVH7pZ3SL0
bioclinica (Yesterday)
Almost here! #PCTrials Pre-arrange a meeting w @bioclinica Drop by & s/w David Kiger & Mike Lange. Mike will give a… https://t.co/8ymd2Q9KcJ
bioclinica (Yesterday)
Almost here! #PCTrials Pre-arrange a meeting w @bioclinica Drop by & s/w David Kiger & Mike Lange. Mike will giv… https://t.co/MpxTDV1T1L
bioclinica (Yesterday)

Latest Blogs:

Removing Risk from Clinical Trial Management System (CTMS) Implementations
Collaboration Between Clinical Operations and the Logistics and Supply Chain Teams is Key to Trial Success
The Value of Protocol Review
CTMS and RBM: Hot Topics at OCT Nordics in Copenhagen
Congressman Meehan and Bioclinica CEO John Hubbard at recent visit to Bioclinica's Audubon offices