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Realize the Benefits of a Fully Developed CTMS Without the Typical Time to Implement, Using OnPoint Direct CTMS

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  • 25 Apr

In our experience, many small- to mid-sized companies view the implementation of a Clinical Trial Management System (CTMS) to be too resource-intensive (finances, time and human resources); because of this and other reasons, many of these companies compromise with systems comprised primarily of manual processes using spreadsheets, half-built internal systems or less-than-ideal implementations. However, CTMS plays an integral role in the conduct of your trials, and the implementation should support your specific needs.

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Top 5 Criteria for Your RBM Software Selection

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  • 20 Apr

There is increasing recognition of the importance of implementing risk-based monitoring (RBM) systems to aid with the monitoring and reporting of relevant risks in clinical trials, rather than relying on traditional methods based on disparate data sources and manual collation processes. Software-based RBM systems automate predetermined monitoring tasks, provide alerts for identified risks and can provide audit trails for regulatory submissions. However, all RBM systems are not the same.

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Risk Management and RTSM

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  • 17 Apr

The revisions in ICH E6 (R2) – Good Clinical Practice has garnered a lot of attention, not least because of the explicit recommendations for the incorporation of a formal risk analysis when planning and executing trials. The starting point for managing risk effectively is adopting a suitable risk analysis and mitigation method, such as risk scoring or failure modes effects analysis. We need to understand what could go wrong (hazard), what happens if it occurs (impact), how likely it is to happen (probability), and how likely we are to realize it has happened (detectability).

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LitTRACE: Simplified Tracking and Assessment of Safety-Related Literature

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  • 12 Apr

The scientific literature has always been a very dependable source of information for identifying drug safety-related information, such as Individual Case Safety Reports (ICSRs), signals, aggregate report relevant information and epidemiology data. Tracking this safety information is mandated by regulatory agencies. Relevant safety information published in national and international journals, including that from local journals, conferences and symposia, are considered for assessment.

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Required eCTD Submissions as of May 5, 2017 – Are You Ready?

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  • 10 Apr

The electronic common technical document (eCTD) is an interface for the pharmaceutical industry to transfer regulatory information based on the Common Technical Document (CTD) format, which is an agreed common format for applications that will be acceptable in all three ICH-Regions (US, EU & Japan) and other countries.

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Biomarkers and Personalized Medicine: Essential Tools

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  • 28 Mar

The use of biomarkers is expanding across all stages in the drug development process, helping bring about new and innovative practices in the treatment of many diseases, including Alzheimer's and cancer. With their ability to revolutionize development of advanced therapeutics, biomarkers have become essential tools.

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Successful Direct-to-Patient Shipping of Study Drugs

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  • 27 Mar

Clinical trials for patients with rare, debilitating diseases who have limited mobility and greater caregiving requirements can be challenging, particularly for clinic visits and medication adherence. But, we like a challenge. In a recent clinical trial, we collaborated with the sponsor to successfully ship the study drugs directly from the depot to a sample of US-based patients with a rare, progressive debilitating disease characterized by motor, cognitive and behavioral symptoms.

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Meet the Bioclinica Financial Lifecycle Solutions Team: Bob Gabriel, Senior Vice President and General Manager, Bioclinica FLS

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  • 17 Mar

Bob Gabriel is the Senior Vice President and General Manager of Bioclinica's Financial Lifecycle Solutions (FLS) division. The FLS suite of financial lifecycle products assists with managing the global automation and financial management of clinical trials and includes ClinPay, a proprietary transaction engine and secure online clinical trial payment network; ClinPlan, a budget management and cash forecasting solution; and ClinDebit, a patient reimbursement solution.

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Pathway to Quality Cardiovascular Imaging Trials

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  • 13 Mar

Cardiovascular diseases are the leading cause of death in the world and as such, the cause, prevention and treatment of all cardiovascular disease remains a very active field in the research community. Cardiovascular Imaging is a primary therapeutic service area for Bioclinica, offering comprehensive centralized medical imaging services and support for the majority of all cardiovascular imaging (CVI) modalities leveraged to provide critical endpoint assessments in clinical research.

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Does Your RBM System Support the Recently Revised Guidelines to Have a QMS in Place?

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  • 03 Mar

The latest International Council for Harmonisation (ICH) Good Clinical Practice (GCP) E6 addendum includes recommendations for ensuring quality management in clinical trials at the forefront. In particular, the new section 5.0 outlines recommendations for quality management, stating that "sponsors should focus on trial activities essential to ensuring human subject protection and the reliability of trial results" within the seven areas that are described below.

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7 Advantages of a Site Network vs. Individual Sites for Clinical Trials

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  • 24 Feb

How many investigative sites will you need for your next clinical trial? Will you choose independently-operated sites or a network of sites? Do you know their differences and advantages? We polled our Research Network customers and staff, and share what they said in this blog.

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Reflections on My Experience at the 2017 DIA Pharmacovigilance and Risk Management Strategies Conference

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  • 22 Feb

Compared with the 2016 Drug Industry Association (DIA) Pharmacovigilance and Risk Management Strategies Conference, the 2017 conference in Washington, D.C. had a much better start. Although I was not at last year's conference, I read the epic testimonials of snowstorms, canceled flights, lockdowns and other interesting events, which were all very entertaining.

This year's DIA Pharmacovigilance and Risk Management Strategies Conference, which I attended, was less eventful, and yet, still full of encounters, lively discussions and as always, laughter.

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Streamline the Financial Management of Your Trials With the ClinPay and ClinPlan Integration

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  • 22 Jun

Although our financial lifecycle solutions are powerful on their own, they provide even greater benefits when used together. This is especially true of ClinPay and ClinPlan; the recent integration of these two products streamlines the financial lifecycle of clinical trials from end to end.

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The Increasing Role of Technology in Supporting ICH E6 R2

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  • 16 Jun

As you may already be aware, a key recommendation in the latest revision to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH E6 R2), finalized in November 2016, is the use of a quality-based approach inclusive of risk-based monitoring (RBM). It also recommends centralized monitoring processes. These should complement and potentially allow you to reduce the extent and frequency of on-site monitoring, freeing up valuable resources and providing the opportunity to:

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Recruiting Senior Citizens for Vaccine Trials Requires Circle of Trust

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  • 15 Jun

Senior citizens tend to have less-than-optimal vaccination rates – even for proven vaccines that bring significant health benefits. Unsurprisingly, then, they are hesitant to engage in vaccine-related clinical trials to test new medications. The way to remove this hesitancy is to engage senior citizens by building a circle of trust: a circle that has as its center the education of both the site staff and potential patients.

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Upcoming Webinar: How Improving Site Payments Can Make You the Sponsor/CRO of Choice

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  • 13 Jun

Join us for our upcoming webinar on June 27th where Lorie McClain, the VP of Product Management and Product Development and Technology at Bioclinica, Inc., and other Bioclinica clinical payments experts will present and discuss case studies illustrating how trial sponsors and CROs are becoming partners of choice at high-performing sites.

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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.

[LIVE WEBINAR 7/25] Pharmacovigilance case studies. https://t.co/wlO43PAptj https://t.co/wCtpPVsS6I
bioclinica (20 minutes ago)
Welcoming our new #eHealth App xChange Partner AB Cube! Get the news via @ClinicalLeader1 #pharmacovigilance https://t.co/EMe2pNjfTD
bioclinica (20 hours ago)
Let's keep the #AAIC2017 convos going! View #Alzheimer clinical trial resources https://t.co/PGVNjLuBCP
bioclinica (20 hours ago)
"Medical record mud run" 1 obstacle in vaccine trials w elderly. Here R 5 more & how to conquer by Dr. Craig Curti… https://t.co/5rO4jURlVF
bioclinica (21 hours ago)
News: AB Cube Joins @bioclinica App xChange. Cloud safety platform a catalyst for transformative safety change https://t.co/vXnRO8YgMa
bioclinica (Yesterday)
Our Medical Imaging team is in the spotlight for a job well done! https://t.co/6DZrRNZc7D
bioclinica (Yesterday)

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