BioClinica Grows eClinical Results in Europe

BioClinica®, Inc., the global provider of clinical trial management solutions, today announced that Europe was the fastest growing geographic region in 2013 for its eClinical technology products. The Company plans continued investments in its European workforce in the areas of operations and sales, potentially doubling its European eClinical presence in 2014. The growing team supports BioClinica’s full suite of eClinical offerings, including CTMSEDCIRT, and clinical supplies planning. Currently, the Company has employees in corporate offices in Lyon, France; Leiden, The Netherlands; and Munich, Germany, with additional personnel in Switzerland, Belgium and the United Kingdom. Continue reading

Mundipharma Research Becomes the Latest Pharmaceutical Company to Choose BioClinica’s Industry-Leading Clinical Trial Management System

BioClinica®, Inc.,a global provider of clinical trial management services, announced today that Mundipharma Research, a dynamic pharmaceutical research and development company has selected BioClinica’s OnPoint CTMS (Clinical Trial Management System). With this decision, Mundipharma Research plans to utilize OnPoint CTMS for various aspects of its clinical trial management activity.

Mundipharma Research selected OnPoint CTMS for its highly adaptive design that complements the company’s approach to pharmaceutical development. OnPoint CTMS is a powerful end-to-end clinical trial management solution that brings improvements in control and efficiency of clinical trials. As a web-based CTMS, it gives sponsors the ability to view and manage real-time operational performance – wherever and whenever.

OnPoint’s Office-Smart capabilities enhance Mundipharma Research’s existing investment in Microsoft technologies by letting users access, update, and report on clinical trial data from within the familiar environment of Microsoft Office and SharePoint. Using SharePoint as a collaborative portal, OnPoint’s web services integration with other trial management products provides an end-to-end trial management solution. This approach greatly enhances user adoption, and helps avoid the pitfalls of less adaptive CTMS products.

“We are very excited about Mundipharma Research’s decision to utilize the OnPoint approach to clinical trial management,” said Peter Benton, President of BioClinica’s eClinical Solutions. “Mundipharma Research is known for being a dynamic organization wholly dedicated to the research and development of highly effective and innovative medications. This requires supporting technologies that empowers users and makes them more productive. OnPoint’s customizable structure and robust reporting capabilities will accomplish this for Mundipharma Research while increasing collaboration and visibility.”

BioClinica will be hosting its first BioClinica European User Conference on February 26th 2014 in Cologne, Germany. Follow BioClinica on the Trial Blazers blog at http://www.bioclinica.com/blog and on twitter at http://twitter.com/bioclinica.

Original Press Release: http://www.bioclinica.com/news-events/press-releases/mundipharma-research-becomes-latest-pharmaceutical-company-choose

Merger to Create Leading Provider of Specialty Outsourced Clinical Services

CCBR-SYNARC and BioClinica, Inc. announced today that they have signed an agreement to merge their companies to create a leading global provider of specialized outsourced clinical services.  The combined company will offer a portfolio of services uniquely tailored to conducting and managing global clinical trials on behalf of the world’s premier pharmaceutical and biotechnology companies.  Jeffrey McMullen, vice chairman of inVentiv Health, Inc., will serve as chairman of the combined company.  Mark Weinstein, president & CEO of BioClinica, will serve as CEO.

Mr. McMullen, who has more than 40 years of experience in the drug development industry, said, “This is a ground-breaking merger that will bring together two of the industry’s most experienced providers of specialized clinical trial services.  Combining CCBR-SYNARC and BioClinica into a single company will offer customers exceptional scientific expertise and sophisticated technologies to support their drug development processes and accelerate the pace of their innovation.”

As one entity, BioClinica and CCBR-SYNARC will become the market-leading provider of four highly specialized services that increase the speed and efficiency of global clinical trials.  The combined company will provide customers with medical imaging services that track the effectiveness of new drugs across multiple therapeutic areas, including oncology, neurology and musculoskeletal. It will offer an extensive worldwide network of research centers dedicated to recruiting patients for global trials.  It will provide state-of-the-art technology and consulting services to support the overall drug development process, as well as services to monitor the cardiac safety of compounds under development.  It also will offer central lab capabilities to analyze biological samples originating from clinical trials.

This merger comes at a time when demand for outsourced pharmaceutical services is projected to grow more than five percent per year over the next five years. Pharmaceutical companies are increasingly turning to specialists to help them manage their drug development processes.

Together, BioClinica and CCBR-SYNARC will serve the world’s leading pharmaceutical and biotech companies through board-certified oncologists, radiologists, cardiologists and medical researchers located in centers throughout Asia, Europe and The Americas.  With nearly 50 years of combined experience, BioClinica and CCBR-SYNARC have completed more than 5,000 clinical trials to support customers with introducing new medicines across key therapeutic areas.

The transaction is expected to close in the first quarter of 2014.  Financial terms are not being disclosed.

You can find the original press release here: http://www.bioclinica.com/news-events/press-releases/merger-create-leading-provider-specialty-outsourced-clinical-services

Enhanced Usability in Allegro CTMS Multi-Site Edition

Managing protocols across multiple sites can be challenging, requiring detailed site selection, study start-up and project management processes.  To alleviate some of the frustrations that can arise and reduce the time allocated to these tasks, many multi-site networks have implemented a clinical trial management system (CTMS) to keep themselves organized and automate some processes.

One clinical trial management system, Allegro CTMS Multi-Site Edition, is designed specifically to meet the needs of these investigator site networks and trial management organizations.  It features components for subject visit management, financials, project management, and site selection, to name a few.  To keep it relevant to industry needs, it is continually being assessed for enhancement opportunities, which are compiled into a release a few times a year.  Recently, the system received several updates, allowing for better workflows and compliance.  Some of these new enhancements include:

  • Visit Tolerances: Tolerance dates for visits have been updated to be more user-friendly, providing this information by date ranges rather than +/- a set number of days.  Additionally, this information can easily be viewed in a pop up window from the home page, allowing for fast and easy rescheduling, when necessary.
  • Visit Scheduling: A variety of components have been added that allow for improved scheduling internally.  An advanced scheduling link allows staff members to allocate time only to the times they are needed rather than cluttering their calendar with all day subject visit events.  Additionally, screening visits have been updated to include a screen fail option, which flows through to financials, enabling proper billing to the sponsor for screen fails versus passes.
  • Site Selection: The site selection component has been enhanced to include customizable questions that can be defined relevant to each organization’s needs.
  • Credentials: The ability to track board certifications and both investigator and staff credentials has been added.  Consolidating all this information into the system makes it easy to find later and monitor when expirations of these credentials are approaching.

These features and more can be found in the newest release of Allegro CTMS Multi-Site Edition.  To learn more, visit http://forteresearch.com/ctms-allegro/

The original press release can be found here: http://www.pressreleasepoint.com/enhanced-usability-allegro-ctms-multi-site-edition

Important Alzheimer’s Research on Display at CTAD 2013

Submitted by Chahin Pachai on October 28, 2013Next month, I will be attending the 6th annual Clinical Trials Conference on Alzheimer’s Disease (CTAD) conference along with fellow members of the BioClinica Central Nervous System therapeutic team including Luc Bracoud, Joël Schaerer and Florent Roche.

At the meeting, we will be presenting volumetric MRI data from Bristol-Myers Squibb’s CN156-018 Alzheimer’s Disease study. The study was the first prospective, randomized, controlled trial in subjects with pre-dementia AD using entry criteria based upon clinical phenotypic features and CSF biomarker criteria.We will have the privilege of presenting four posters (listed below and on the CTAD conference website) prepared in collaboration with the Bristol Myers Squibb’s Alzheimer Disease (AD) and Imaging teams. The posters focus on volumetric MRI and PET results from BMS study CN156-018 including:

  • Longitudinal whole brain, ventricular and hippocampal atrophy rates of the CN156-018 cohort compared with ADNI-1.
  • Comparison of Tensor Based Morphometry (TBM) and Boundary Shift Integral (BSI) for assessing whole brain, ventricular atrophy.
  •  Predictive value of baseline hippocampal volume and brain amyloid burden on atrophy rates for predementia AD subjects.
  • 2D and 3D image quantification strategies for assessing intracranial volume using MRI.

The volumetric MRI results from this study were obtained by applying BioClinica’s fully-automated image processing and quantification methods.

Link to original post: http://www.bioclinica.com/blog/important-alzheimer’s-research-display-ctad-2013

Allergopharma Gastgeber des 3. BSI CTMS User Group Meetings

BSI Business Systems Integration AG lädt zur CTMS-Fachveranstaltung. Gastgeber des 3. BSI User Group Meetings für Clinical Trial Management Systems ist Allergopharma GmbH & Co KG

Am 24. Oktober 2013 treffen sich Experten für Clinical Trial Management Systems (CTMS) bei Allergopharma GmbH & Co KG  in Reinbek bei Hamburg, um über die neusten Funktionen in BSI CTMS zu diskutieren. Die Präsentation des Release, Priorisierung der Roadmap und Austausch unter BSI CTMS Anwendern stehen im Fokus dieses User Group Meetings. Allergopharma ging im vergangenen Jahr mit BSI CTMS produktiv und erweiterte 2013 neue Module aus der neuesten BSI CTMS Produktversion 5.1.

Die 1969 gegründete Allergopharma in Reinbek bei Hamburg ist ein Unternehmen der in Darmstadt ansässigen Merck Gruppe, einem der weltweit führenden Pharma-, Chemie- und Life-Science-Unternehmen. Allergopharma bietet einen professionellen Rundum-Service für Ärzte und Kliniken und organisiert Weiterbildungs-Symposien für Fachkreise.

Allergopharma ist seit mehr als 30 Jahren in der Forschung und Entwicklung tätig. Nicht zuletzt durch das wissenschaftliche Engagement gehört Allergopharma zu den Marktführern bei Präparaten zur spezifischen Immuntherapie (SIT) sowie bei Produkten für die Prävention und stellt als einziger Anbieter im deutschsprachigen Raum Allergenextrakte selbst her.
Im März 2012 ging BSI mit dem Clinical Trial Management System (CTMS) bei Allergopharma, einem international tätigen Spezialisten für die Erforschung, Produktion und den Vertrieb von Produkten zur Diagnostik und Therapie der Typ-1-Allergie, produktiv:  Allergopharma organisiert mit BSI CTMS das gesamte klinische Studienmanagement. Mit der professionellen Lösung können Studien über ihren kompletten Lebenszyklus geplant, durchgeführt und überwacht werden. Ausserdem werden mit dem System die Kosten laufender und geplanter Studien kalkuliert. Insgesamt rund  50 Nutzer arbeiten europaweit bei Allergopharma und den beauftragten Clinical Research Organizations (CROs) mit BSI CTMS.

Im Mai 2013 startete die zweite Projektphase: Vor allem die Module für Medikamentenversand und Finanzplanung wurden erweitert. Die Allergopharma Mitarbeiter profitieren von einem zeitsparenden Importmodul und vielen weiteren Funktionalitäten, die mit der neuesten BSI CTMS Produktversion 5.1 zur Verfügung stehen.

Mehr Effizienz in der Studienverwaltung

Excel und sonstige Insellösungen gehören der Vergangenheit an. Mit BSI CTMS konnte Allergopharma die Effizienz der Studienverwaltung deutlich steigern. Darüber hinaus hat das Unternehmen jederzeit einen sofortigen Überblick über Kosten, Medikamentenversand und relevante Entscheide. Änderungen werden lückenlos protokolliert, mögliche Fehlerquellen reduziert.

Allergopharma schätzt besonders die übersichtliche Darstellung der Studien, die einfache Benutzeroberfläche und die intuitive Anwendung. Mit dem Finanzmodul ermöglicht BSI CTMS einen exakten Forecast zur Budgetierung der Studien. Dokumentvorlagen, Lagerverwaltung und Versand von Studienmaterial sind übersichtlich in einer Anwendung zusammengefasst.

Gewissenhafter Evaluierungsprozess

Allergopharma prüfte im Rahmen eines umfassenden Evaluierungsprozesses 12 CTMS-Systeme auf Herz und Nieren. Schliesslich kamen drei Anbieter in die engere Auswahl, BSI CTMS war einer davon. «Was BSI für uns geschaffen hat, konnte uns kein anderes Tool bieten. Das System ist einfach zu bedienen und deckt unsere Bedürfnisse optimal ab. Besonders das Drug Shipment und die Finanzplanung waren wichtige Anforderungen für Allergopharma. Ebenso das sehr gute Preis-Leistungsverhältnis sprach für BSI», erklärt Oliver Rossol, Projektleiter CTMS bei Allergopharma.

Original Press Release here.

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Medidata Launches Novel Study of Technology-Enabled Patient Engagement on Changing Health Outcomes in Diabetes Community

First Medidata-Sponsored Clinical Trial Will Use mHealth Devices Linked to Cloud Technology for Lifestyle Management

NEW YORK, N.Y. – September 19, 2013 – Medidata Solutions (NASDAQ: MDSO), the leading global provider of cloud-based solutions for clinical research in life sciences, today announced the sponsorship of its first clinical trial, which will evaluate the impact of mobile and cloud-based technology on patient engagement for improved health outcomes in the diabetes community.

By providing patients with the tools they need to track behavioral factors such as weight and physical activity, the pioneering study will test whether technology can increase the rates of therapy adoption and drive better outcomes for people with diabetes. Medidata’s study will use mHealth devices that provide immediate feedback to participants and are wirelessly linked to targeted messaging for unique patient engagement.

The study is in collaboration with Medidata Technology Partner Spaulding Clinical Research, a leading clinical research solution provider and medical device manufacturer, which will use its capabilities to enable the mHealth devices to connect to the Medidata Clinical Cloud™.Withings, a top innovator in health and wellness smart devices and applications, will supply the mHealth devices that will monitor the physical activity and weight of study participants. Leading endocrinologist Dr. Zachary T. Bloomgarden, Clinical Professor of Medicine, Endocrinology, Diabetes and Bone Disease at Mount Sinai Hospital in New York and co-editor of the Journal of Diabetes, is the study’s principal investigator. The initial feasibility stage of the study is slated to start in the fourth quarter of 2013 and will be followed by a randomized clinical trial.

“We are proud to sponsor our first clinical study in collaboration with Spaulding and Withings to see how disruptive technology can improve patient engagement and actually lead to better medical outcomes,” said Glen de Vries, president of Medidata Solutions. “Since our beginning, Medidata has pioneered the use of technology to transform clinical research, and the opportunity to see our technology used to improve patient health in the critical area of diabetes care is a logical—and incredibly exciting—extension.”

More than 20 million Americans have been diagnosed as having diabetes, the number nearly doubling in the past decade due to factors including lack of physical activity and obesity, resulting in significant individual and societal impacts and costs. Through activity monitoring devices, uploaded data and targeted feedback, the Medidata-sponsored study will explore the potential of technology tools to improve overall levels of patient adherence to lifestyle changes. The feedback provided to patients will address exercise levels as well as diet and regular use of recommended medications.

Randy Spaulding, founder and CEO of Spaulding Clinical Research, said, “Wireless and personal mobile devices provide opportunities to improve patient engagement because of their ease of use, real-time transmission of data and increased portability and convenience. This collaboration is an important step in bringing these benefits to the real world.”

“One of the major challenges in diabetes management is working with patients to adopt lifestyle changes,” added Dr. Bloomgarden. “Most diabetics have to live with this chronic condition for a long time, so using personal devices and patient engagement apps to improve quality of life would be very powerful and a huge win for our clinical care models.”

Link to original Press Release: http://www.mdsol.com/medidata-launches-novel-study-technology-enabled-patient-engagement-changing-health-outcomes-diabetes-community

5 Strategies for Speed and Quality Data in High Volume Clinical Trials

Submitted by Jennifer Kelly on September 6, 2013

Are you a clinical trial data manager concerned that any of the following pose a threat to your data quality?

  • A clinical trial with a large patient population
  • Reconciliation of multiple data points
  • Aggressive timelines and massive amounts of data

If you’re wrestling with these issues, you’re not alone. Maintaining quality along with speed and volume is a real balancing act for data managers — and it’s becoming increasingly more difficult as the industry is challenged to hold down rising costs while accelerating therapies to market.

Learn strategies to achieve both quantity and quality data in large-scale clinical trials, including those with thousands of subjects, during the annual SCDM Conference in Chicago. On September 12th, I will be presenting “Key Steps in Maximizing the Production of Quality Data in High Volume Clinical Trials.”

You’ll find strategies in all areas of clinical data management, including:

  • eCRF Development and Design – Learn how CDASH requirements can be a big time-saver, plus how to decrease user error and queries by simplifying your forms.
  • System Functionality – See how derivation and work flow edits can reduce data entry errors and cleaning time by effectively using enable/disable and hard trap.
  • Data Review – Hear how you can simplify data review on even the most complicated eCRFs using the MedRA and WHO Drug Dictionary. See how to track unacceptable query responses and how to maximize reviewer time by changing the way forms are assigned.
  • Ancillary Data Integration– Discover what vendor data is really needed to import for data cleaning.
  • Quality Control – Learn the best time to perform QC data review and how often it should be done.

Link to original post: http://www.bioclinica.com/blog/5-strategies-speed-and-quality-data-high-volume-clinical-trials