Please Wait...

Classic Blog

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

Why Your RBM System Should be SMART, Not Pretty

  • 0
  • 09 Feb

There is long-standing recognition that Risk-Based Monitoring (RBM) is essential to ensuring the safety of your patients and the success of your clinical trial. Data quality and patient safety are also at the core of quality by design (QbD) initiatives, which focus on identifying key risks to subject safety, data quality and GCP/regulatory compliance, setting the foundation for RBM implementation.

Read More

Pages

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

Pages

LEARN MORE OR SPEAK WITH OUR EXPERTS

CONTACT US
Leader in Clinical Trial
Management Solutions

Bioclinica is divided into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging and Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Biomarker Laboratory. Our eHealth segment comprises an eClinical Solutions Division along with Safety and Regulatory Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

@ArenaIntPharma pls contact our events coordinator via traditional channels
bioclinica (30 minutes ago)
eHealth Solutions president Mukhtar Ahmed speaking at #phorum17 Apr. 27 https://t.co/OaBPodxZBF https://t.co/QjHQR1LbU1
bioclinica (54 minutes ago)
Join @Bioclinica April 28 at NJ Statewide Career & Internship Fair, Rutgers Univ. https://t.co/NH3wsToDTh
bioclinica (1 hour ago)
RT @MySCRS: 96.7% of patients want to know results of #ClinicalTrials yet only 9% are able to find them after study ends. https://t.co/SxtG…
bioclinica (1 hour ago)
RT @SCDM_DataDriven: SCDM is looking for volunteers to revise the Certification Exam! Are you interested? Learn more https://t.co/X7ZYvur2fm
bioclinica (1 hour ago)
RT @ACROhealth: Follow #CTAW2017 next week to learn how more #clinicaltrial participation could help us discover better treatments. https:/…
bioclinica (1 hour ago)

Latest Blogs: