Please Wait...

Classic Blog

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

  • 0
  • 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.

Read More

Top 5 Criteria for Your RBM Software Selection

  • 0
  • 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.

Read More

Risk Management and RTSM

  • 0
  • 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).

Read More

LitTRACE: Simplified Tracking and Assessment of Safety-Related Literature

  • 0
  • 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.

Read More

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

  • 0
  • 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.

Read More

Biomarkers and Personalized Medicine: Essential Tools

  • 0
  • 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.

Read More

Successful Direct-to-Patient Shipping of Study Drugs

  • 0
  • 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.

Read More

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

  • 0
  • 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.

Read More

Pathway to Quality Cardiovascular Imaging Trials

  • 0
  • 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.

Read More

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

  • 0
  • 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.

Read More

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

  • 0
  • 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.

Read More

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

  • 0
  • 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.

Read More

Pages

Fixing delays in study site activation: 3-Fold Solution

  • 0
  • 04 Aug

What's behind slow site activation?

Sean Stanton of Bioclinica Research provides meaningful insights on study site activation in his latest article, 'Improving Site Activation: Three-Fold Solution' published in ICT's August 2017 issue.

Read More

Cardiovascular Imaging: Not Just for Cardiovascular Trials

  • 0
  • 03 Aug

Cardiovascular disease is the leading cause of death globally with approximately 17.3 million deaths annually. Underlying heart disease are numerous conditions such as atherosclerosis, myocardial infarction, ischemic stroke, heart failure, arrhythmias and heart valve issues.

Read More

Patient Engagement in Alzheimer's and Mild Cognitive Impairment Clinical Trials

  • 0
  • 02 Aug

Considering the large number of individuals affected by Alzheimer's disease (AD) or Mild Cognitive Impairment (MCI), you might expect fast enrollment into clinical trials. The reality is quite different. Sponsors of clinical trials face several obstacles: 1) Patients are underdiagnosed. 2) Patients have a limited knowledge of clinical trials and some misconceptions. 3) AD/MCI clinical trials are complex, prohibiting participation.

Read More

Upcoming Webinar: Outsourcing Pharmacovigilance: Pros and Cons and Lessons Learned

  • 0
  • 21 Jul

Join us for our upcoming webinar on July 25th during which Sukrit Singh and Dr. Ayesha Hussain, both pharmacovigilance experts who are also Associate Directors of CRM at Bioclinica, Inc., will present and discuss case studies illustrating how market authorization holders and CROs are becoming partners of choice in the ever-changing world of pharmacovigilance outsourcing.

Read More

Pages

LEARN MORE OR SPEAK WITH OUR EXPERTS

CONTACT US
Leader in Clinical Trial
Management Solutions

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 @eClinical_Jen: FREE on-demand webinars from @bioclinica on EDC, Imaging, RBM, and Clinical Trial Management. Tell them I sent you! http…
bioclinica (14 hours ago)
Excited to host NJ Lt. Gov. Kim Guadagno, clients, partners 9/28 in Princeton! In the area? Join us ! RSVP… https://t.co/PrfyxvasGb
bioclinica (Yesterday)
Be sure to follow #ThankAScientist all week to thank researchers for the work they do! https://t.co/Sfi9mmHbSk… https://t.co/y9ZhBXsIzu
bioclinica (2 days ago)
Cardiovascular imaging use is growing in non-cardiovascular areas #ClinicalTrials. See where in Tim Crowe's blog… https://t.co/dYjPBC0Wtn
bioclinica (2 days ago)
RT @Xtalks: Cardiovascular Safety in #Biopharmaceutical Product Development - From QT Prolongation and Beyond @bioclinica https://t.co/mCk1…
bioclinica (2 days ago)
RT @Xtalks: How Innovations in Data Visualization Are Accelerating Data Cleaning and Improving Quality @bioclinica https://t.co/vfLU8pS9Rd
bioclinica (2 days ago)

Latest Blogs: