Bioclinica and ArisGlobal seek to transform pharmacovigilance

In an effort to improve the pharmacovigilance model, they look to comprehensive cloud solutions to help lower costs, raise quality

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DOYLESTOWN, Pa.—Bioclinica Inc., a specialty clinical trials technology and services provider, announced in April the selection of ArisGlobal’s Safety Cloud as the preferred safety platform for its pharmacovigilance services. Under this partnership, Bioclinica becomes the preferred partner for ArisGlobal in business process consulting and change management as sponsors implement or upgrade ARISg. Together, the partnership reportedly brings a flexible delivery model that fits any organization regardless of size or case volume.
A top-20 pharmaceutical company has already selected Bioclinica to standardize its safety case processing service on the ArisGlobal platform, while two other companies are making the switch from competing platforms.
“Early adoption speaks to the strength and value of our joint solution in addressing industry’s long-wanted desire for such a safety offering,” said Bioclinica’s president of eHealth Solutions, Mukhtar Ahmed.
ArisGlobal Vice President of Safety George Philips added: “Through our partnership with Bioclinica, we are able to provide the pharmaceutical industry with an unprecedented level of streamlined and cost-efficient end-to-end pharmacovigilance services.” The cloud-based solution replaces traditional on-premise safety systems unpopular with many organizations due to burdensome management, maintenance and fiscal challenges, he noted, saying, “By utilizing these services, resources within an organization can now be shifted to address other pressing needs.”
ArisGlobal, and Bioclinica’s Safety and Regulatory Solutions division (formerly known as Synowledge), formulated this comprehensive partner strategy to deliver cost-effective and regulatory-compliant services. Bioclinica’s Global Consulting group provides organizations with business and change management expertise when implementing or upgrading to new versions of ARISg, including return on investment optimization, standard operating procedure creation, system validation and development of agile database conventions.
“The formation of this partnership addresses the full continuum of pharmacovigilance as a service,” Ahmed remarked. “Together Bioclinica and ArisGlobal provide the most comprehensive solution, whether an organization wants to handle safety internally or outsource it to our team of safety experts.”
Looking toward the next wave of innovation, the partners are already working closely to develop ArisGlobal’s next generation of products, which combine medical knowledge with innovative technologies derived from such areas as artificial intelligence, machine learning and natural language processing.
Bioclinica’s president of Safety and Regulatory Solutions, Sankesh Abbhi, said, “We are creating solutions that remove the struggle involved in assembling the required safety reports, which can be especially difficult in studies where therapies carry intense safety monitoring requirements. ArisGlobal currently has an extraordinarily high customer satisfaction rating, and our investment in innovation and automation demonstrates, in return, our commitment to our customers.”
ArisGlobal’s cloud-based solutions facilitate global drug development and regulatory compliance within the life-sciences and healthcare industries. Its cloud platform supports the entire product life cycle, including clinical development, regulatory affairs, pharmacovigilance and medical communications.
Bioclinica is a specialty services provider that utilizes expertise and technology to create clarity in the clinical trial process. Bioclinica is organized by separate business segments to deliver focused service supporting multifaceted technologies. The Medical Imaging and Biomarkers segment provides medical imaging and cardiac safety services and includes a molecular marker laboratory. The eHealth Solutions segment comprises the eClinical Solutions platform, Clinverse Financial Lifecycle Solutions, Safety and Regulatory Solutions, Strategic Consulting Services, App xChange Alliances and eHealth Cloud Services.

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