Sponsors

To learn more about sponsorship and exhibition opportunities, please contact Dor Peled at dpeled@exlevents.com or 917-258-5159

2020 Sponsor:

Veeva Systems

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Veeva Systems

Veeva Systems Inc. is a leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva has more than 625 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices in Europe, Asia, and Latin America.

2019 Sponsoring Organizations:

CGI

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CGI

CGI is one of the largest IT and business process services providers in the world with a deep commitment to providing innovative services and solutions. CGI provides innovative, end‑to‑end IT and business consulting services through our client-proximity business model, working side-by-side with clients and drawing upon our global capabilities to help identify, develop, implement and operate the strategies and solutions needed to meet their customer and citizen expectations. CGI works with life sciences companies to deliver better business outcomes. Through our deep industry expertise, we help pharma, biotech, and medical device firms transform their businesses to drive high performance, compliance and digital connectivity.

Complion

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Complion

Complion’s mission is to reinvent site regulatory and document management by eliminating human error and redundant work to achieve maximum efficiency and compliance. We are the first and are the largest eRegulatory platform built for sites, health systems, academic medical centers, and cancer centers.

Florence

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Florence

Florence eBinder Suite is the eRegulatory solution trusted by sites and sponsors around the world. Visit us to discover how we accelerate trial startups, give sponsors clearer insights into the status of their sites, enable remote monitoring, and facilitate stronger connections with researchers.

GxP Quality Systems

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GxP Quality Systems

GXP Quality Systems LLC (GXPQS) is an independent consulting company that provides product lifecycle, preclinical and clinical research and regulatory affairs consulting services ranging from research and development to commercialization. Our experts have used a proprietary regulatory/quality systems approach to establish custom Quality Systems in numerous companies, from small US-based startups and mid-sized internationals (including China and India) to large multinational pharmaceutical firms. GXPQS has enabled the regulatory compliant development and product approval of biopharmaceuticals, cosmetics, drugs, biologics, gene therapies, medical devices, vaccines, combination products, and in vitro diagnostics. Our experience encompasses most therapeutic areas including cardiology, dermatology, gastroenterology, endocrinology, oncology, immunology and virology. Please visit our website www.gxpqsllc.com to learn more about the services we offer.

InnovoCommerce

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InnovoCommerce

InnovoCommerce’s investigatorFIRST completes your eTMF’s functionality, digitizing, tracking & automating previously manual document exchange workflows between site & sponsor/CRO. Multiple top20 Pharma customers see both manpower & cycle time reduction of over 80%, with demonstrated cost savings of $450k+/trial. investigatorFIRST gives you real-time monitoring of both site & sponsor document status, providing real-time views into expected vs actual counts and timeliness, dramatically reducing regulatory risk and increasing eTMF quality & inspection readiness.

inSeption

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inSeption

inSeption’s insistence upon securing the “right” people to integrate into a true partnership alliance with its clients eliminates the vulnerability so often felt by operational leaders faced with evaluating traditional outsourcing options. inSeption’s core competency of identifying and securing the most experienced and proficient professionals builds the crucial foundation of a successful drug development program. Actively collaborating with its clients to custom design, hand select and assemble high-performing project teams empowers inSeption to tailor its services specifically to meet the needs of their programs. The inSeption model provides increased control, full transparency of project deliverables and timelines, and significant operational and cost efficiencies.

Just in Time GCP

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Just in Time GCP

Just in Time GCP supports small and mid-size pharma companies and CROs in managing their Trial Master Files. Whether you are anticipating a regulatory inspection, need resourcing for routine quality oversight of your TMFs or are planning the implementation of a TMF system, Just in Time GCP can support you. We have extensive industry experience in clinical operations and truly understand the complexities of trial management and drug development. We partner with your organization in ensuring that your TMFs are inspection-ready. We take the stress out of TMF management.

LMK Clinical Research

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LMK Clinical Research

LMK Clinical Research Consulting, LLC, (LMK) is a global Functional Service Provider of Trial Master File (TMF) consulting and TMF services. LMK specializes in the strategic development, project management and quality control of documents and content that support clinical development. A combination of TMF expertise and an extensive knowledge of the clinical drug development process have helped LMK become a trusted leader in the life sciences industry with a reputation for quality.

MasterControl

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MasterControl

MasterControl quality management software and services enable research and manufacturing companies in the life sciences to increase compliance while reducing time to market. MasterControl offers solutions for the entire enterprise, including clinical, regulatory and quality management with document control (e.g. GxP); document management (e.g. eTMF); study management; monitoring; audit management; regulatory submission management; training management; supplier management; deviation management; CAPA; and more.

Medidata

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Medidata

Medidata Edge eTMF makes overseeing clinical trial artifacts simple. As a collaboration platform that empowers all stakeholders, from sponsors, sites and CROs to manage and jointly work on an entire TMF life cycle, Edge eTMF allows users to seamlessly and accurately manage both content and data while maintaining inspection readiness and compliance. As the centerpiece of the Medidata Clinical Cloud document strategy, Edge eTMF powers trials to run faster, lowers risks managing regulated content and delivers higher quality real-time document management while requiring fewer resources and reducing complexity.

Edge eTMF streamlines search results, powers real-time compliance and reduces filing complexity with instant TMF content auto-population.

Micro Focus

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Micro Focus

Micro Focus is a global software company with 40 years of experience in delivering and supporting enterprise software solutions that help customers innovate faster with lower risk. Our portfolio enables our 20,000 customers to build, operate and secure the applications and IT systems that meet the challenges of change. Everything we do is based on a simple idea: the fastest way to get results from new technology investments is to build on what you have–in essence, bridging the old and the new.

Montrium

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Montrium

Montrium is a global leader in regulated electronic content management solutions and GxP Consulting Services for the Life Sciences. With over 10 years of experience in the clinical research and drug development arena, our team has developed a range of intelligent and dynamic solutions for document and quality management. eTMF Connect, an Electronic Trial Master File (eTMF) solution, centralizes and standardizes your clinical records enabling both sponsors and CROs to contribute and access information in real time. eTMF Connect has been built to:

  • Facilitate the exchange of clinical trial information to all stakeholders
  • Accurately track the progress of eTMF Completeness
  • Quickly comply with Regulatory Requirements, Audits and Inspections
  • Accelerate Study & Site Startup
  • Enhance the Quality and Integrity of Clinical Documentation

Phlexglobal

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Phlexglobal

Phlexglobal are the Trial Master File (TMF) experts, and pioneers in the provision of innovative, flexible and technology-enabled TMF solutions and services.

A specialist provider of electronic Trial Master File (eTMF) solutions and other support services to the global clinical research market, we offer a unique combination of technology, quality and services that deliver a range of flexible, targeted solutions to the life science industry.

TransPerfect

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TransPerfect

TransPerfect provides a collaborative web-based platform for study start-up and eTMF that enables sponsors, CROs, IRBs, central laboratories and other vendors to maintain and update clinical trial documentation in a secure online environment. TransPerfect's Life Sciences division is dedicated to working with clients on a global, collaborative level, supporting a wide range of requirements including product licensing and alliance management, endpoint adjudication, eTMF review/reconciliation, and pharmacovigilance.

Veeva Systems

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Veeva Systems

Veeva Systems Inc. is a leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva has more than 625 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices in Europe, Asia, and Latin America.

Wingspan – an IQVIA Company

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Wingspan – an IQVIA Company

Wingspan, an IQVIA company, provides an ECM platform for the life sciences industry in a high-performance, scalable, validated cloud environment. Our industry-leading eTMF process is used by sponsors and CROs of all sizes to manage trials from planning through archival. Wingspan provides the transparency needed to understand TMF health and inspection readiness, along with tools to support and measure the productivity of eTMF processes. As a result, eTMF contributed significantly to supporting our clients’ record of successful health authority inspections.

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