Medidata, TriNetX, and Datavant Partner to Enable Seamless Integration of Real-World Data in Clinical Development

Medidata | October 30, 2020

Medidata, a Dassault Systèmes company, TriNetX, and Datavant announced a partnership that will accelerate the use of real-world data (RWD) to power clinical research. Linking RWD, which are data not collected during the specific context of the trial, can help improve understanding of the long-term safety and efficacy of new therapies. This partnership will enable users of Medidata’s end-to-end clinical research platform to securely link their clinical data with patient consent to de-identified patient data without unblinding the study. The solution leverages Datavant’s Patient Key technology and data ecosystem, as well as RWD from TriNetX’s global network of healthcare organizations who participate in this program

Spotlight

Custom ICM solutions are built for you, not auditors, so they typically don’t offer visibility into actions performed over time. Auditors may lack confidence in your homegrown system, especially if they find errors or omissions. In fact, audit risk from errors and overpayments is often the most compelling reason we see customers switch from build to buy. New regulations place additional burdens on your commissions system.

Spotlight

Custom ICM solutions are built for you, not auditors, so they typically don’t offer visibility into actions performed over time. Auditors may lack confidence in your homegrown system, especially if they find errors or omissions. In fact, audit risk from errors and overpayments is often the most compelling reason we see customers switch from build to buy. New regulations place additional burdens on your commissions system.

Related News

PHARMA TECH

Gerresheimer and Zollner enter into a strategic partnership for electronically controlled medtech systems from a single source

Gerresheimer AG | August 18, 2022

Gerresheimer AG and Zollner Elektronik AG are pooling their market-leading pharmaceutical and medical technology expertise under a strategic partnership. Starting immediately, they will offer pharmaceutical, healthcare and biotech companies their conceptual design, development and manufacturing capacities for drug delivery and medical technology systems, including complete electronics, from one single source. Gerresheimer serves as the central point of contact for customers. The market-leading partners combine the expertise of Gerresheimer in innovative devices for the administration of medicines and medical technology systems with the globally established electronics expertise of Zollner. Together they want to further develop their expertise in the healthcare sector and open up new markets. With this strategic partnership, Gerresheimer and Zollner are counting on the global trend toward electronic, digitally controllable and connected drug delivery and diagnostic systems. These include insulin pens, inhalators, like for people suffering with asthma, Point-of-Care systems and medicine pumps. The demand for medical and pharmaceutical devices with electronic components mostly for the treatment of chronic illnesses will significantly increase in coming years. According to studies, the market for digital and connected solutions for the treatment of diabetes alone is expected to grow to around EUR 11bn by 2025. Zollner Elektronik AG is one of the world's largest manufacturing service providers for electronic and mechatronic components (Electronic Manufacturing Services or EMS). It generated revenues of around 1.9 billion Euros with just over 12,000 employees at 23 locations in Germany and abroad, 18.3% of that in the area of Healthcare & Life Sciences. "The future belongs to digital treatment support with electronic systems and connected platforms. The partnership with Zollner helps us provide our pharma customers with innovative one-stop medtech solutions. For patients, using these solutions means better treatment and enhanced quality of life. At the same time, the healthcare system also benefits by way of permanently reduced treatment costs." Dietmar Siemssen, CEO of Gerresheimer AG "Digitalization of medical devices is advancing at a very fast tempo. At Zollner, we are happy to have found an ideal partner in Gerresheimer for the expansion of our successful Healthcare & Life Sciences efforts," says Markus Aschenbrenner, Managing Board Member at Zollner. "Together we will expand access to existing markets, exploit new growth markets and support our mutual customers along the entire life cycle of the products." Zollner and Gerresheimer have collected much cooperation experience in numerous projects. The electronics specialist in Zandt already supplies Duesseldorf-based Gerresheimer with components and assemblies for medicine pumps in Parkinson's therapy. Gerresheimer and Zollner are now further developing this cooperation and will act as equal partners for the healthcare system of the future. Through the integration of concept design, development and manufacturing, the products of both sides can be brought to market faster and more efficiently. Also gained is permanent, secure access to electronic components. The cooperation initially covers the development of inhalers for chronic lung disease sufferers, autoinjectors, ophthalmology systems and drug pumps, as well as contract manufacturing for these and similar devices.

Read More

BUSINESS INSIGHTS

Alira Health Expands North American Capabilities with the Acquisition of Artisan Healthcare Consulting

Alira Health and Artisan Healthcare Consulting | September 07, 2022

Alira Health, a patient-centric, global health care advisory, clinical research and technology company, announced the acquisition of Artisan Healthcare Consulting, a US-based consulting firm that provides strategic insights to healthcare companies. Artisan serves 12 of the top 15 pharmaceutical companies in the US, supports the C-Suite of leading biotechnology companies, and has deep expertise in over 30 therapeutic areas. The acquisition of Artisan strengthens and extends Alira Health’s Market Access and Management Consulting advisory practices in North America and globally. Clients of Alira Health and Artisan Healthcare Consulting now have access to the full breadth of advisory offerings from both firms. Alira Health clients can leverage Artisan’s deep expertise in brand strategy and analytics, new product differentiation, US market access, go-to-launch strategies, and product lifecycle management. Artisan Healthcare Consulting clients can benefit from Alira Health’s clinical operations, real-world evidence, and patient-centric technology offerings, including decentralized clinical trials (DCT), patient support programs (PSP) and digital therapeutics (DTx). “Artisan Healthcare Consulting is recognized for delivering the highest level of strategic and quantitative analysis to help healthcare leaders act decisively across their business. Artisan Healthcare Consulting’s leadership has decades of experience serving as a long-term partner to healthcare executives. We welcome them to the Alira Health team.” Jean-Francois Ricci, Chief Access Officer at Alira Health “We are delighted to join a company with such a broad and complementary set of capabilities,” said Bob Delise, CEO and Founder of Artisan Healthcare Consulting. “It is a pleasure to work with our new colleagues, and we now have access to an international team of strategists and experts who can help our customers succeed. We embrace Alira Health’s mission to humanize healthcare and look forward to offering new capabilities to all our clients.” Artisan Healthcare Consulting partners Bob Delise, Brad Ship, and Greg Wolfe will join Alira Health’s global consulting leadership team as they continue to work with their long-term clients. About Artisan Healthcare Consulting, Inc. Artisan Healthcare Consulting Inc. was founded in 2009 on the principle that outstanding client service differentiates a great consulting firm from a good one. Artisan provides strategic and analytic advice to a wide range of healthcare product companies. Artisan works across the biopharma industry to help clients steer emerging therapies through clinical development, launch them successfully, and drive success throughout the life cycle of their products. About Alira Health Alira Health is an international patient-centric, global health care advisory, clinical research, and technology company, whose mission is to humanize healthcare. We work with healthcare and life sciences organizations looking for support across their entire solutions lifecycle. From development to medical care, we complement our clients’ expertise with a full spectrum of services including research and clinical development solutions, technology-powered consulting, and real-world evidence. Our integrated and multidisciplinary team of over 600 scientists, strategists, economists, clinicians, and biostatisticians collaborate across our North American, European, and Asian offices and advise 80% of the top 50% of MedTech companies and 75% of the top 50% of Pharma companies.

Read More

BUSINESS INSIGHTS

Societal CDMO Selected To Provide Tech Transfer And Manufacturing Services To Support Clinical Development Of An Oral Solid Dose Product In Europe

Societal CDMO, Inc. | July 21, 2022

Societal CDMO, Inc. a contract development and manufacturing organization dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, today announced that it has been selected to provide CDMO services to support the ongoing clinical development of a novel drug candidate in Europe. The compound is an oral solid dose anti-viral therapy product approved for the prevention and treatment of human immunodeficiency virus in select countries in Europe and Societal’s work is focused on supporting the expansion of the product’s indications. Under terms of the new agreement, Societal CDMO will execute appropriate technology transfer activities, followed by cGMP manufacture of clinical trial material to support the initiation and execution of Phase 2 studies of the drug candidate. This work will include production, packaging and labeling of both the active compound and matching placebo for the study. “This is a key new agreement for Societal CDMO as it is a clear demonstration of the company’s ability to capitalize on the increasing interest of drug developers in the onshoring and reshoring of contract manufacturing activities to the U.S. from other regions around the globe. We are proud to be trusted by our partner to execute the tech transfer, manufacturing and packaging services that will be necessary for the initiation of its planned Phase 2 study in Europe. We continue to be pleased with our progress in leveraging our end-to-end CDMO service offerings to grow our business and expand our client base.” David Enloe, chief executive officer of Societal CDMO About Societal CDMO Societal CDMO is a bi-coastal contract development and manufacturing organization with capabilities spanning pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms with a primary focus in the area of small molecules. With an expertise in solving complex manufacturing problems, Societal CDMO is a leading CDMO providing therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging and logistics services to the global pharmaceutical market. In addition to our experience in handling DEA controlled substances and developing and manufacturing modified-release dosage forms, Societal CDMO has the expertise to deliver on our clients’ pharmaceutical development and manufacturing projects, regardless of complexity level. We do all of this in our best-in-class facilities, which total 145,000 square feet, in Gainesville, Georgia and San Diego, California.

Read More