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

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

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 Things Every Data Manager Should Know When It Comes to Medical Images in Clinical Trials

Submitted by Colin Miller on September 9, 2013

This week the annual Society for Clinical Data Management (SCDM) conference, the world’s largest educational event for clinical data managers and related professionals, will be held in Chicago. I have been invited to give a talk aimed at clinical data managers, highlighting some of the complexities and challenges associated with trials containing imaging endpoints.

While preparing for my presentation and thinking about the challenges that are faced by data managers, I put together the following checklist of what I consider best practices for managing and processing imaging data in clinical trials.

1. Understand the Imaging Review Charter

Clinical trials with imaging endpoints require an Imaging Review Charter (IRC). The IRC serves as a roadmap for standardizing and interpreting data coming from trials containing imaging endpoints, providing a comprehensive and detailed description of the clinical trial imaging methodology. It is important to ensure that the Charter and export specifications document match with respect to the primary endpoints.  Although additional data or assessments not described in the Charter may be exported, the key assessments have to match the content of the Charter. An understanding of the IRC will help ensure that a data manager is in tune with the overall flow of data for the trial and is up to speed with all imaging data that will fall under their supervision.

2. Understand your imaging data

Data managers should be familiar with the imaging endpoint(s) being measured in a given study. Different endpoints provide different data outputs. Some data are quantitative at the time of acquisition (e.g. PET and DXA scans) while other data are derived from image measurements (e.g. lesion area or volume). Another type of data output are scoring systems, which are commonly used in many therapeutic areas (Genant for osteoporosis or Sharp modified for RA) and provide semi-quantitative data. Familiarizing yourself with the measurements feeding into an eCRF is crucial to understanding and validating data and will facilitate the development of appropriate edit checks for a study.

3. Develop the edit checks being applied to your imaging data early in the process

Developing optimum edit checks for each imaging endpoint is important to ensure high quality data. Different imaging endpoints will require different edit checks due to the inherent variability of different modalities and measurements.  Longitudinal studies (e.g. lesion tracking for oncology studies) provide multiple measurements and track differences over time, making it necessary to understand the extent of variability which can be tolerated in a given measurement. Imaging core labs are often tasked with performing edit checks, so it is critical for the data manager to understand these edit checks and the rationale behind choosing them.

4. Understand the read design

The read design for a clinical trial ultimately dictates the imaging data that will pass through the hands of the data manager. Different clinical trials utilize different reader paradigms, from a relatively straight-forward single reader to more complex paired reads with adjudication. The choice of read paradigm is based on a number of factors including study phase, regulatory compliance, operational efficiency, and cost-benefit. By understanding the selected reader paradigm, data managers can understand the flow of data in a trial and can anticipate the amount of data he/she will be handling throughout the course of the trial.

5. Visit the core lab

Although this may sound obvious, I encourage all data managers working on an outsourced clinical trial to establish a relationship with the vendor of your study. For clinical trials in which an imaging core lab is utilized for centralized image analysis, it is important to be involved in communications with the core lab from the start of the trial. Visiting the core lab and participating in conference calls between the sponsor and core lab are good ways to ensure open lines of communication during the course of the trial.

With medical imaging playing a prominent role in today’s clinical trials, data managers must be aware of the challenges associated with managing complex imaging data. The SCDM is an important conference and I’m looking forward to sharing my thoughts on this topic at the meeting. I hope to see you there!

Link to original post: http://www.bioclinica.com/blog/5-things-every-data-manager-should-know-when-it-comes-medical-images-clinical-trials

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

Perceptive Informatics Improves Clinical Trial Management with New Release of Impact® CTMS Solution

Boston, MA, U.S., April 3, 2013 — Perceptive Informatics, a leading eClinical solutions provider and a subsidiary of PAREXEL International Corporation (NASDAQ: PRXL), today released an enhanced version of its comprehensive IMPACT® clinical trial management system (CTMS). Notable features include improved data entry as well as site management and monitoring capabilities. The system is designed for pharmaceutical and biotechnology companies of all sizes, and has more than 26,000 users in studies of up to tens of thousands of subjects and millions of visits.

According to market research firm MarketsandMarkets, the CTMS software industry is expected to jump from $567.2 million in 2010 to $1.3 billion by 2016.[1]  Perceptive Informatics’ CTMS solution provides a user-friendly infrastructure that enables clinicians to manage trials of varying complexity.

“Many top global pharmaceutical companies and CROs rely on the IMPACT CTMS solution to plan, administer and track every aspect of their clinical trials,” said Nick Richards, Vice President, Product Management, Perceptive Informatics. “As clients face further globalization of clinical trials and require site management and monitoring of increasingly complex studies, they need technology that keeps pace. Perceptive’s enhanced system represents a significant leap forward in flexibility and usability, enabling clients to improve the speed and effectiveness of their clinical development programs.”

Perceptive’s enhanced version is a customizable system which allows managers the flexibility to define which information is most important to their clinical trial and configure it accordingly. Highlights include:

  • Configurability by Clinical Trial Type – Customers can define their own clinical trial types – from single-site investigator-initiated studies to large multi-country studies – enabling them to select the critical screens and fields that each requires. This simplifies and streamlines clinical trial management and ensures that users see exactly what they need.
  • Assistance for Field Monitors – The IMPACT® MySites™ Module, which supports online and offline monitoring activities and the collection of associated management data, now enables contract research associates to record and manage contacts for the sites they monitor, allowing them to have a more comprehensive view of site activity.
  • Improved Data Mining Capabilities – The IMPACT® Investigator Module’s advanced search feature enables users to select physician names based on their location, specialty, therapeutic interests, responses to qualification questionnaires and investigator performance metrics in order to speed the finalization of candidate study sites and the recruitment of optimal investigators for a trial.

Perceptive Informatics’ IMPACT CTMS solution is used to plan, track and report on clinical trials and is available as a hosted, software-as-a-service (SaaS) application. It is an integral part of the Perceptive MyTrialsTM platform, which provides an application framework to converge its integrated suite of clinical trial software. For more information visit: http://www.perceptive.com/ctms/impact

[1] MarketsandMarkets, “Clinical Trial Management Systems (CTMS) Market: Global Trends, Opportunities, Challenge and Forecasts (2011 – 2016),” January 2012.

– See more at: http://www.perceptive.com/news/press-releases/2013/perceptive-informatics-improves-clinical-trial-management-with-n/#sthash.fSP9Faxy.dpuf

SIRO Clinpharm Selects Oracle Health Sciences InForm to Increase Clinical Trial Productivity and Support Global Electronic Data Capture

Latest Win Strengthens Oracle Health Sciences’ Momentum Across Asia

Redwood Shores, Calif. – Jan. 8, 2013

News Facts

To more efficiently conduct and manage electronic data capture (EDC)-based clinical trials on behalf of its clients, SIRO Clinpharm, winner of Frost & Sullivan Indian Clinical Research Organization (CRO) of the year award, 2012 and 2011, recently selected Oracle Health Sciences InForm.
SIRO Clinpharm’s purchase of Oracle Health Sciences InForm extends the company’s investment in Oracle Health Sciences clinical applications, on which it has built its rapidly expanding CRO business.
In addition to selecting Oracle Health Sciences InForm, SIRO Clinpharm gained a competitive advantage by joining the Oracle CRO Advantage Program – a program that provides a framework for driving CRO success with Oracle Health Sciences products through training, sales and marketing support and tools, and regular communications on Oracle products and strategy.
With its sophisticated data review capabilities, Oracle Health Sciences InForm will enable SIRO Clinpharm to have better control over its data, and the company expects to see significant efficiency and productivity gains in data management and remote monitoring.
Oracle Health Sciences InForm will also provide SIRO Clinpharm flexibility to set targeted source verification strategies that allow for rapid increases or decreases of the source verification workload based on data quality.
Extensive study templates and library management capabilities within Oracle Health Sciences InForm will enable SIRO Clinpharm to accelerate the study-build process and provide sponsors with significantly faster trial implementation.
SIRO Clinpharm will benefit from Oracle Health Sciences InForm’s scalability, performance and multi-language capabilities to deploy global trials.
Oracle Health Sciences InForm is part of a comprehensive portfolio of Oracle Health Sciences Cloud Applications and is powered by the Oracle Health Sciences Cloud to help customers accelerate IT deployments, reduce resources required to maintain IT infrastructure and gain a more predictable IT spending pattern.
SIRO Clinpharm has built a state-of-the-art technology offering that includes Oracle Health Sciences InForm, Oracle Clinical, Oracle Remote Data Capture, Oracle’s Siebel Clinical Trial Management System and Oracle Adverse Event Reporting System.

Supporting Quotes

“As a leading clinical research organization, we looked at the best in class EDC solutions available on the market.  We selected Oracle Health Sciences InForm because we believe it clearly stands out from its competitors with outstanding functionality, low total cost of ownership and satisfied end users worldwide,” said Gopa Menon, chief executive officer, SIRO Clinpharm.
“SIRO Clinpharm has a long-standing commitment to Oracle Health Sciences clinical applications,” said Neil de Crescenzo, senior vice president and general manager, Oracle Health Sciences. “The addition of Oracle Health Sciences InForm will extend SIRO Clinpharm’s clinical data management and EDC capabilities to support a growing number of trials, including global EDC studies, while optimizing its existing Oracle Health Sciences investment.”

About Oracle

Oracle engineers hardware and software to work together in the cloud and in your data center.  For more information about Oracle (NASDAQ:ORCL), visit www.oracle.com.

About Oracle in Industries

Oracle industry solutions leverage the company’s best-in-class portfolio of products to address complex business processes relevant to health sciences, helping speed time to market, reduce costs, and gain a competitive edge.

About SIRO Clinpharm

SIRO Clinpharm, winner of the 2012 & 2011 Frost & Sullivan Indian Clinical Research Organization of the year award, is a drug development solutions provider to the global healthcare industry. Our subject expertise gives us an edge in data management, medical writing, biostatistics & clinical trial management. With a successful track record of 16 years, SIRO Clinpharm works with most of the top global biopharma & medical device companies. Our therapeutic experience includes but is not limited to oncology, diabetes, cardiology, infectious diseases & respiratory system. We offer flexible business models across service verticals based on client needs.

Trademarks

Oracle and Java are registered trademarks of Oracle and/or its affiliates. Other names may be trademarks of their respective owners.

Link to original press release: http://www.oracle.com/us/corporate/press/1892279