December 4, 2017 | November was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from Bracket, Johnson & Johnson, Bioclinica, and more. 

Bracket announced the addition of Christopher Crucitti, Chief Commercial Officer to its global executive team. Crucitti joins Bracket as an experienced commercial leader in clinical and R&D services. Crucitti brings industry-recognized experience, knowledge and integrity to Bracket's leadership team as well as notable accomplishments in training and motivating other commercial professionals to provide a high level of customer service and overall performance. He will be responsible for the global commercial strategy and development of Bracket's electronic clinical outcomes assessments (eCOA) and patient engagement platform, Randomization and Trial Supply Management (RTSM), Rater Training and Quality Assurance as well the Company's expanding mobile suite for patient diary and analytics, among others. "It's with great excitement that we welcome Chris to our leadership team," said Jeff Kinell, CEO at Bracket, in a press release. "Chris brings an impressive resume in clinical commercial strategy to Bracket and has joined us at a pivotal time, as we continue to position ourselves competitively in the global marketplace through the increased use of Bring Your Own Device mobile solutions for patient engagement. We look forward to the unique and seasoned perspective Chris will bring to our team and global commercial strategy." Press release

Johnson & Johnson announced developers at CertaDose have won its latest QuickFire Challenge: Advancing the Safe Use of Healthcare Products. The challenge called for potentially game-changing, early stage, innovative ideas to help advance the safe use of healthcare products. Selected from among nearly 100 applicants, the winner will receive a research grant totaling $100,000, as well as entrance to a Johnson & Johnson Innovation, JLABS site, and mentoring from experts at Johnson & Johnson Office of the Chief Medical Officer. CertaDose is a novel pediatric dosing system designed to reduce errors in calculating pediatric dosing for injectable medicines by simplifying the process for calculating milligrams per kilogram body weight. "With prescription medication errors causing at least one death every day and injuring approximately 1.3 million people each year, our goal was to positively impact health outcomes by connecting with entrepreneurs, academics, scientists, engineers or startup companies who are advancing exciting new solutions in medication safety," said Joanne Waldstreicher, Chief Medical Officer, Johnson & Johnson, in a press release. Press release

Bioclinica announced the launch of Bioclinica Clinical Adjudication, a transformational offering in which medical specialists and researchers, backed by advanced technology, lead independent Clinical Event Committee (CEC) review. The new service enables the independent adjudication of clinical events in conformance with regulatory requirements governing clinical trials within all therapeutic areas, including cardiac studies and for Major Adverse Cardiac Events (MACE) committees. Adjudication committee members located anywhere around the globe are able to access Bioclinica’s web-based system to securely and efficiently review clinical event dossiers. Built-in access control and tracking provides for security, protection and audit trail transparency while giving adjudicators ready access to the required information on every clinical event type. “Bioclinica’s robust electronic adjudication environment allows clinical study sponsors to successfully modernize from paper-based adjudication to a web-based system for greater efficiency, data integrity, and reduced timelines while breaking down geographic barriers,” said David Herron, President Medical Imaging & eHealth Solutions, Bioclinica, in a press release. As a key component of the service, Bioclinica brings in a vast network of medical professionals who specialize in the specific endpoint areas, augmented by Bioclinica’s advanced clinical adjudication software for thorough and efficient review of clinical events. As an alternative to tapping this vast network of medical experts experienced in adjudication, sponsors may use their own recommended adjudicators. Press release

Bioclinica has also appointed David Herron as the company’s next Chief Executive Officer, effective January 2, 2018. This follows the planned retirement of current Chief Executive Officer, John Hubbard, who will remain as a non-Executive Director on the Bioclinica Board. With more than 10 years’ of experience at Bioclinica, David Herron has led the company’s Medical Imaging business to great success. During his tenure, he integrated three of the industry’s leading medical imaging companies (Bioclinica, Corelab Partners, and Synarc) into one comprehensive service provider. Focusing on both operational excellence and process efficiency, Herron has grown the business into the world’s largest independent supplier of medical imaging services for clinical trials. Recently Herron assumed the additional responsibility of leading Bioclinica’s technology-focused eHealth segment, immediately creating new synergies that leverage Bioclinica’s multi-faceted capabilities. With appointment to CEO, his oversight will extend to Bioclinica’s network of investigator sites and patient recruitment businesses for a unified clinical trial service offering unmatched in the industry. Press release

Medidata and ICON announced a new collaboration to enhance the management of medical imaging during drug development research. ICON will expand its use of the Medidata Clinical Cloud to include image management services for end-to-end digital control of the healthcare industry’s fastest growing data source. ICON, a Medidata CRO partner since 2005, will now leverage Medidata Medical Imaging to manage imaging studies through a single, unified cloud platform. With Medidata imaging technology, ICON customers, including sponsors and sites, will have the added benefit of configurable and near real-time image access; enhancing speed and facilitating analysis during clinical trials. Press release

PerkinElmer recently announced the launch of PerkinElmer Signals Medical Review. This new cloud-based analytics and visualization solution provides medical monitors in clinical development with smarter insights to quickly detect safety signals and reduce time to submission. The growing volume and complexity of clinical trial data is putting medical monitors at risk of missing safety signals. In addition, manual tracking processes could result in delayed or rejected submissions, market withdrawal, and compromise the safety of clinical trial subjects. PerkinElmer Signals Medical Review aggregates clinical and laboratory data and provides medical monitors with visual analytics most applicable to their roles via tailor-built workflows. This innovative approach to getting timely, critical information to the appropriate recipients is combined with advanced analytics from TIBCO Spotfire software. With the platform, reviewers can quickly respond to questions, uncover trends and outliers across Clinical Data Interchange Standards Consortium (CDISC) domains and identify risks from a single interface in near real-time. The solution’s secure cloud-based infrastructure is user-friendly and allows for faster setup of new studies. Its intuitive interface provides 360-degree visibility with built-in patient profiles, configurable alerts, and medical review status reporting and tracking. Press release

The Mehmet Akif Ersoy (IMAEH) hospital in Istanbul has joined the network of hospitals on Clinerion’s PRS platform. The Istanbul Mehmet Akif Ersoy Hospital provides care for all medical indications, with specialization in cardiology and pulmonology. The hospital’s catchment area has a population of 4.5 million. It is the only training and research hospital for cardiovascular surgery on the European side of Turkey. It is also the only public hospital in Turkey with an international health accreditation awarded by the Joint Commission International. IMAEH will have more than 600 beds in 2018, including an intensive care unit with 174 beds. With PRS IMAEH will be able to identify and recruit patients also in an emergency setting. IMAEH adds more than 2 million medical records and 260,000 patient lives to PRS. Joining the PRS platform means that IMAEH will become more visible to international sponsors seeking sites for clinical trials. Patients at IMAEH will now have access to a wider range of treatment options and physicians at IMAEH will be able to offer a better standard of care. PRS performs medical data analytics on EHR-based patient data from its network of partner hospitals for the purposes of patient search and identification for clinical trials, data generation for real-world evidence and market access activities. Clinerion guarantees patient privacy through the exclusive use of anonymized patient data, while still enabling the re-identification of candidates for clinical trials by authorized hospital staff via the use of its patent-protected “Anonymous Identification” (ANID) technology. Press release

WIRB-Copernicus Group (WCG) announced that it is partnering with Veeva Systems to improve the speed and accuracy of institutional review board (IRB) document transfer. WCG will build a seamless connection between WCG’s MyConnexus IRB document management web portal and Veeva Vault eTMF. By linking Vault eTMF with MyConnexus, IRB documentation can be automatically uploaded into the customer’s Vault eTMF to provide inspection-ready eTMF documents immediately, and reduce the possibility of human error during IRB document transfer. This eliminates the need for clinical trial teams to download documents from the IRB portal only to upload them into their eTMF platform, along with the associated applied metadata. Study documents and associated data are seamlessly transferred from one application to another without human intervention, thereby saving significant time and effort, while increasing the reliability of interactions. “WCG’s goal is to increase the efficiency of the clinical trial process, while maintaining the highest level of human subject protection. Partnering with Veeva will save our clients significant document transfer time and increase the accuracy of the process. This new integration will eliminate any lag time between finalizing an IRB document and uploading it to Veeva Vault eTMF,” said Jill Johnston, president of the WCG Clinical Service Organization, in a press release. Press release

WCG also announced its acquisition of Vigilare. Donald A. Deieso, Chairman and CEO of WCG, said in a press release, “With its comprehensive service suite, Vigilare provides clients with streamlined, regulatory compliant operations, faster access to safety data and focused in-depth product safety reporting and analysis. Vigilare saves clients time and money by offering them a robust alternative to building and maintaining an internal pharmacovigilance and drug safety program.” Like the other members of the WCG family of companies, Vigilare will continue to operate as an independent service organization. WCG will support Vigilare as it continues to expand, with access to capital, complementary clinical and regulatory expertise, and corporate support. Press release

Euformatics has released an improved version of its CE-marked omnomicsNGS software that incorporates the AMP/ASCO/CAP Standards and Guidelines for the Interpretation and Reporting of Sequence Variants in Cancer. The AMP/ASCO/CAP guidelines establish a four-tiered system based on clinical evidence from drug labels, guidelines, and peer-reviewed publications for categorizing the clinical significance of somatic sequence variants based on evidence of their impact on cancer care.  The guidelines were published in January following their development by a multidisciplinary working group from the Association for Molecular Pathology (AMP) with participation by the American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP). ”With the integration of the AMP/ASCO/CAP guidelines into omnomicsNGS, molecular pathology labs are now able to continue to enjoy the flexibility and scalability of the omnomicsNGS platform while being confident in their reporting of both the clinical relevance of somatic variants and the associated treatment options and clinical trials available to the oncologist” states Euformatics CTO Jussi Volanen in a press release. The omnomicsNGS solution is unique for labs that require deep integration. The software goes beyond cloud only-based solutions to enable labs to not only install on local on-site servers but to also independently integrate databases or data sources and population-specific data. ”This is especially important for labs with their own strict data security requirements or labs analyzing data from populations different from general populations,” Euformatics CSO, Chistophe Roos, commented in a press release. The integration capabilities of omnomicsNGS also allow labs to integrate into complex IT infrastructures that include third-party solutions and EHR/EMR.  Therefore, labs have the opportunity to more easily pursue large scale collaboration at the intersection of the clinic, research, biobanking, and even pharma, facilitating rapid knowledge-base growth and exchange. Press release