Interested in becoming a Sponsor? Apply Here!

Sponsors

Would you like to learn more about sponsorship and exhibiting opportunities at the 7th Trial Master File (TMF™) Summit? Please contact Eric Morrin, Senior Business Development Manager, at +1 212-400-6228 or emorrin@exlevents.com.

ArisGlobal

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ArisGlobal

ArisGlobal is the visionary technology company that’s transforming the way today’s most successful Life Sciences companies develop breakthroughs and bring new products to market. Designed with deep expertise and a long-term perspective that spans more than 30 years, our cognitive technology platform, LifeSphere™, integrates machine learning capabilities to automate all core functions of the product life cycle.

Corementum

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Corementum

Corementum helps clients with the Trial Master File Management and Regulatory Submissions Operations necessary to acquire agency approval for regulatory applications in the biotech and pharmaceutical organizations. We help companies who conduct clinical trials to standardize and organize their information that is compliant with the regulations set by the agencies. Corementum assists clients with information management but with compliance, regulation and timely approval of clinical trials by the agency. We are passionate about helping our clients receive the agency approval they need in a timely manner. We make it work the first time!

DRS Corp

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DRS Corp

DRS Corp is a technology and services company focused on eTMF solutions and TMF services for over 30 years. DRS’ TMF OneSource offers customers a variety of 21CFR Part 11 proprietary hosted validated eTMF solutions, document processing, TMF audit, platform migration and oversight services. DRS’ strategy is to have your TMF audit- and inspection-ready 24/7. DRS carries out business globally with sponsors and CROs from its headquarters in New Jersey.

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.

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.

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

NCGS

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NCGS

NCGS, Incorporated is an international full-service CRO, providing clinical development support to pharmaceutical, biotechnology, medical device and diagnostic companies. NCGS’ business model is discernibly different from the industry standard: Utilizing highly tenured staff, NCGS consistently delivers studies on time, within budget and of the highest quality. NCGS is a WBENC-certified diversity supplier, has been in operation for more than 30 years, and supported the approval or expanded labeling of 34 products with zero 483s.

NCGS understands that the CRO-Sponsor relationship is one of shared vision, complementary expertise and trust. NCGS’ team understands the demands of the life science industries, seeking ways to make each clinical effort more quality-based, thorough, timely and cost-effective.

NCGS’ mission is to protect research subjects, capture quality data and maintain the integrity of science with the same passion one would protect their own domain. Each staff member is charged to function under the mantras, “This product could easily be used on your parent, sibling or yourself.” and “It is not only our hope for this product, it is the world’s hope for this product.”

Paragon

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Paragon

Paragon is a consulting firm that helps health and life sciences companies become high-performing, compliant, and digitally connected. Paragon powers business transformation and delivers better business outcomes by providing valuable consulting services as a trusted partner to our clients. We do this by building long-term client relationships based on our domain expertise, creative ideas, pragmatic consulting services, and quality delivery of solutions.

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.

Rho

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Rho

Rho, a contract research organization (CRO) located in Chapel Hill, NC, provides a full range of services across the entire drug development process. For more than 30 years, Rho has been a trusted partner to leading pharmaceutical, biotechnology, and medical device companies as well as academic and government organizations. Our commitment to excellence, innovative technologies, and therapeutic expertise accelerate time to market, maximize returns on investment, and lead to an exceptional customer experience.

Syntel

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Syntel

Syntel (Nasdaq:SYNT) is a leading global provider of automation-driven IT and knowledge process services. Syntel helps global enterprise build agile, efficient technology infrastructures that blend legacy business models with disruptive digital innovations. Our 23,000+ employees believe in building collaborative partnerships and long-term business value for clients by investing in IP, solutions and industry-focused delivery teams with deep domain knowledge. Learn more at www.syntelinc.com.

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 200 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. For more information, visit www.veeva.com.

Wingspan Technology, Inc.

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Wingspan Technology, Inc.

Wingspan Technology, a QuintilesIMS 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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