BUSINESS INSIGHTS

With Veeva eConsent, Celerion is changing the consent experience for clinics and patients

Veeva Systems | October 07, 2021

Veeva Systems  (NYSE: VEEV ) announced that Celerion has  launched Veeva eConsent , a  MyVeeva for Patients  solution, to provide electronic consent for its Phase I clinical trials obtain. With Veeva eConsent, Celerion is moving from manual and paper-based consent forms to a fully digital process. The company uses Veeva eConsent for several studies and has already given their consent to more than 200 test subjects.

Covid-19 limited the time we could spend with attendees. So we needed new and digital ways to advance our studies while meeting regulatory requirements for proper consent, 

- Staci McDonald , Executive Director, Scientific Clinical Operations at Celerion .

An easy-to-use solution that can keep pace with our fast-paced environment and improves the participants' understanding of the study processes. The implementation of the solution went smoothly, and the feedback from the study teams, on-site staff and participants was positive. "

Celerion, a leading global provider of early clinical research services, uses  Veeva SiteVault  to digitally create, manage and distribute informed consent (ICF). Patients can then securely access the eConsent document and complete the consent process via a mobile device. This simplifies the comparison of documents and reduces the administrative effort for the locations. Thanks to a seamless flow of information, Celerion has a complete overview of the status of consent and can thus improve study compliance and monitoring.

Celerion is driving industry collaboration by leveraging digital solutions that enable patient-centric, paperless clinical trials, Veeva eConsent improves the process of informed consent for everyone Stakeholders by providing an intuitive and digital experience for patients and easy collaboration with locations and IRBs for sponsors. 

- Tim Davis , vice president, MyVeeva for Patients at Veeva Systems.

About Veeva Systems
Veeva is the world's leading provider of cloud software for the life science industry. Veeva is committed to innovation, product quality and customer success, serving more than 1,000 customers from the world's largest pharmaceutical companies to emerging biotech companies. As a not-for-profit, Veeva is committed to aligning the interests of all stakeholders, including customers, employees, shareholders and the industries it serves.

Spotlight

View our top five tools and resources to help pharmacists with completing CPD. Head over to our website to find out how we can support you with your CPD.

Spotlight

View our top five tools and resources to help pharmacists with completing CPD. Head over to our website to find out how we can support you with your CPD.

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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.

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BUSINESS INSIGHTS

LTS takes next step in its Growth Journey with the acquisition of Tapemark Inc.

LTS Lohmann Therapie-Systeme AG | August 23, 2022

LTS LOHMANN Therapie-Systeme AG announces the closing of the acquisition of Tapemark Inc. located in St. Paul, MN, USA. This acquisition combines Tapemark, a world-class CDMO specialized in transdermal drug delivery systems and oral thin films as well as unit dose semi-solid drug and iontophoresis products with LTS, a leading pharmaceutical technology company that develops and manufactures innovative drug delivery systems such as Transdermal Patches Oral Thin Films and Micro Array Patches (MAP) for major Bio- /Pharmaceutical, Generic, and Consumer Health companies. With the acquisition, Tapemark´s St. Paul facility will become part of the worldwide operations network of LTS, along with LTS' existing facilities in Andernach, Germany and West Caldwell, NJ in the US. Bas van Buijtenen, CEO of LTS, commented, "We are very pleased to welcome the Tapemark team to the LTS family. This strategic acquisition demonstrates our commitment to continue to set the standard as the best CDMO in TTS and OTF and to strengthen our footprint in the US, the world's most important pharma market. We will offer an even more complete portfolio of drug delivery expertise and expanded manufacturing capabilities to our customers and their patients, and we are excited to welcome Tapemark's customers to LTS' global network. The acquisition strengthens our R&D capabilities in North America, allowing us to bring ever more innovation and development support to players developing innovative therapies and new drug delivery systems. With that, we're even better positioned to address our customers' desire for a single partner to support them from feasibility through commercialization. We are particularly pleased that such a talented team is joining our organization. I am delighted that Beau Garrett will be strengthening our Global Leadership Team in the role of SVP Strategy and Corporate Development. His track record as a leader successfully driving growth will bolster our LTS Growth Journey." "Joining LTS strengthens our ability to craft the best product development and manufacturing strategy to deliver complex drugs for our customers who ultimately bring these to market and help patients around the world. Having spoken to our customers, I know they are excited to benefit from the breadth of LTS's global technology portfolio, its product development capabilities, and the vast global network. Together, we will reach more pharmaceutical partners and ultimately help more patients. Personally, I am pleased our executive team is joining such a strong team at LTS. From the day I met Bas and several of the senior leaders at LTS, I knew this was the right fit for both companies, our employees, and our customers." Beau Garrett, CEO of Tapemark The transaction has obtained the necessary regulatory approvals and has closed as of August 19, 2022. Financial details of the transaction are not disclosed. Bourne Partners served as the exclusive financial advisor to Tapemark. About LTS LTS LOHMANN Therapie-Systeme AG is a leading pharmaceutical technology company that develops and manufactures innovative drug delivery systems such as Transdermal Patches and Oral Thin Films for the pharmaceutical industry. LTS maintains its leading position through the continuous refinement of its core TTS and OTF technologies and by advancing emerging drug delivery technologies, including Micro Array Patches for the transdermal delivery of large molecule, biological actives and vaccines. Founded in 1984, LTS operates today from three sites: in Andernach, Germany, West Caldwell, NJ, USA and St. Paul, MN, USA. LTS has also a representative office in Shanghai, China.

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BUSINESS INSIGHTS

Mission Bio Announces Pharma Assay Development Services for Solid Tumor Research

Mission Bio | July 13, 2022

Mission Bio, Inc., the pioneer in high-throughput single-cell DNA and multi-omics analysis, announced the launch of solid tumor assays through its Pharma Assay Development services. The availability of this new service offering will help to accelerate the development of cancer therapeutics by reducing the time and cost associated with the characterization of solid tumor cells. Precision therapeutics for solid tumors have been historically bottlenecked due to technical challenges associated with the ability to deeply profile thousands of individual cells for a rich characterization of tumor evolution and heterogeneity. This must be done at a much higher resolution compared to bulk next-generation sequencing to enable detection of rare events, at a much earlier stage before progression. Utilizing Mission Bio's Tapestri™ platform, the company's PAD services for solid tumors partner with researchers to provide high-resolution data to unmask the underlying genetic diversity across cell populations. Insights into the clonal landscape and co-occurrence of mutations enable improved patient stratification for clinical trials and the identification of druggable targets for precision therapeutics. Researchers can also monitor treatment resistance by analyzing the acquisition of rare mutations driving tumor progression over the course of treatment. The expansion of Mission Bio's PAD services to solid tumor research comes just three months after the launch of the Solid Tumor Solution on the Tapestri™ Platform, demonstrating Mission Bio's commitment to continuously developing innovative single-cell technologies for its pharma customers. "We have seen tremendous uptake and interest from top-tier pharma companies for our blood cancer Pharma Assay Development program, and we expect the same momentum for our solid tumor services. With our solid tumor services, Mission Bio partners with pharma customers to elucidate the mechanisms of drug resistance through mutation acquisition, determine how cells transform from benign to malignant states, and reveal the genomic changes enabling cancer cells to metastasize – without having to bring single-cell technology or resources in-house. From a customer's perspective, it is as easy as shipping out samples and getting a fully analyzed report back." Todd Druley, MD, PhD, Chief Medical Officer of Mission Bio Mission Bio's PAD services deliver comprehensive support across the therapeutic development process. The company has a dedicated team that works with researchers to develop assays, identify high-impact samples, and analyze the data. As part of the service, pharma partners have access to Mission Bio's innovative technology, assay development team, R&D organization, and bioinformatics support. About Mission Bio Mission Bio is a life sciences company that accelerates discoveries and cures for a wide range of diseases by equipping researchers with the tools they need to better measure and predict our resistance and response to new therapies. Mission Bio's multi-omics approach improves time-to-market for new therapeutics, including innovative cell and gene therapies that provide new pathways to health. Founded in 2014, Mission Bio has secured investment from Novo Growth, Cota Capital, Agilent Technologies, Mayfield Fund, and others. The company's Tapestri™ platform gives researchers around the globe the power to interrogate every molecule in a cell together, providing a comprehensive understanding of activity from a single sample. Tapestri™ is the only commercialized multi-omics platform capable of analyzing DNA and protein simultaneously from the same sample at single-cell resolution. The Tapestri™ Platform is being utilized by customers at leading research centers, pharmaceutical, and diagnostics companies worldwide to develop treatments and eventually cures for cancer.

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