Resource Library
Brochures
TopCase Studies
Abbott: Transforming Clinical Business with an Enterprise Approach to EDCLowering Clinical Trial Costs with a Trial Planning and Budgeting Application
Solving the Compliance Challenge for Investigator Clinical Research Payments
Meeting the Challenges of a Multinational Late Phase Study
Mastering Mid-Study Changes: ICON Clinical Research Draws on Medidata Rave for Smooth Data Migrations
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Industry Analyst Reports
Health Industry Insights (IDC): Medidata Brings Intelligent Design to Clinical TrialsHealth Industry Insights (IDC): EDC in Clinical Trials: An ROI Analysis of Medidata Rave
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Medidata Perspectives
Applied Clinical Trials online features a Medidata Insights™ benchmark on source data verification, posted in January as the first of a monthly series highlighting industry metrics.Read
In the fall issue of The Security Journal, Medidata's vice president of information security and privacy, Glenn Watt, discusses how organizations can view information security strategically in software development without falling victim to high costs.
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In the December issue of Journal for Clinical Studies, Medidata authors Jessica Dolfi and Sondra Pepe discuss the impact of the impending Sunshine Act on clinical trial sponsors.
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In eCliniqua’s December issue, Medidata’s Michelle Marlborough, director of product management, and Joshua Pines, senior product marketing manager, encourage protocol authors to think of themselves as data archaeologists, analyzing previous research to uncover and replicate best practices.
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Medidata’s vice president of partnerships and alliances, Graham Bunn, notes the qualities of effective CRO-sponsor relationships in Life Science Leader’s December issue.
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Medidata director of product marketing Stan Haavik, traces the development of interactive response technology (IRT) systems used in clinical trials for randomization, supply planning and implementation, in the December issue of Applied Clinical Trials.
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In the December issue of European Pharmaceutical Review, Medidata’s senior director of development Jeffrey Cohen and senior product marketing manager Joshua Pines discuss the standards created to help simplify integration between clinical technology solutions, and the external systems managing EHRs and medical images.
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Patrick Chassaigne, director, late phase solutions, explores the patients role in Phase IV studies and registries, in the November/December Year in Preview issue of PharmaVOICE. Vice president of clinical solutions Jeffrey Handen also weighs in on engaging the patient as a drug development partner and president Glen de Vries highlights three top trends impacting R&D.
Read (Patrick Chassaigne) | Read (Jeffrey Handen) | Read (Glen de Vries)
In a PharmExec guest blog post, Medidata director of late phase solutions Patrick Chassaigne discusses ways to drive patient participation in post-approval studies.
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In the autumn 2011 issue of International Clinical Trials, Medidata’s vice president of data operations Lori Shields discusses the importance of new technological tools that help sponsors and sites meet their budget needs and increase study efficiency.
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Medidata director of product marketing Stan Haavik discusses the importance of process efficiency in clinical trial randomization in the June issue of PharmaVOICE.
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In the summer issue of European Pharmaceutical Contractor, Medidata senior product marketing manager Joshua Pines discusses how life science organizations can maximize the impact of EDC adoption by revisiting their internal processes and analytics tools.
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Medidata associate product manager Keyur (Kevin) Shroff discusses six steps to streamlining the contracting of sites for clinical studies in the March issue of Journal for Clinical Studies.
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Medidata vice president of regulatory policy Pat Beers Block and senior product director Steve Young provide commentary on the high cost and questionable impact of 100% SDV in the February issue of The CenterWatch Monthly.
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Medidata senior director of product marketing Ron Rubinstein discusses why EDC offers an elegant solution to reducing the burden of SAE reporting for both sites and sponsors in the January/February issue of Bio-IT World.
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Medidata business consultant Jessica Dolfi explains how to optimize a site budget in a diverse and rocky world in the December issue of Scrip Clinical Research.
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Medidata senior product director Steve Young and director of strategic initiatives Ashwin Mundra equip clinical organizations on the right tools to execute risk-based site monitoring in the November/December issue of VIEW on E-Solutions.
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Medidata vice president of channel sales and head of EMEA Steve Heath focuses on Australia as an emerging global clinical research destination in the September issue of the Journal for Clinical Studies.
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Medidata senior product director Steve Young and director of strategic initiatives Ashwin Mundra discuss risk-based site monitoring and partial source document verification as the new paradigm in the September issue of European Pharmaceutical Contractor.
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Medidata director of strategic initiatives Ashwin Mundra discusses the new paradigm in site monitoring in the September issue of Life Science Leader.
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Medidata vice president of operations Lori Shields and manager of data quality and analytics Rafael Campo discuss reimbursement and protocol complexity trends in the June issue of VIEW on Clinical Operations.
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Medidata business consultant Jessica Dolfi, manager of data quality and analytics Rafael Campo and other industry experts share how study managers can master currency fluctuations in global clinical trials in the June issue of Applied Clinical Trials.
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Medidata client services principal Thomas Ermlich explains how companies can maximize their eClinical strategies through process optimization, technology implementation and industry knowledge in the spring issue of European BioPharmaceutical Review.
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Medidata vice president of alliances Anne Zielinski discusses what makes the right menu for clinical trials technology in the April issue of Life Science Leader magazine.
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Medidata vice president of information security and privacy Glenn Watt shares lessons from the trenches of clinical development technology for cloud computing security in the January issue of Bio-IT World.
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Medidata vice president of implementation services David Gemzik and other industry experts discuss the CDISC protocol representation model for optimizing clinical research via standardization in Volume 4 of Drug Development.
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Medidata vice president of implementation services David Gemzik offers tips for a healthy clinical trial
with the help of high-quality protocol development programs in the December issue of European Pharmaceutical Contractor.
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Medidata vice president of alliances Anne Zielinski examines if Contract Research Organizations (CROs) and Electronic Data Capture (EDC) are a match made in heaven or an uneasy alliance in the November/December issue of Contract Pharma.
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Medidata vice president of implementation services David Gemzik and senior product marketing manager Sean Cheng explain why sponsors need an integrated, closed-loop clinical process in the November issue of VIEW on E-Solutions.
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Medidata vice president and head of EMEA Steve Heath and senior director of quality assurance Tony Hewer discuss how technology can aid in the relationship between society, regulators and the life sciences industry in the November issue of Life Science Leader.
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Medidata vice president and head of EMEA Steve Heath explains how small and mid-sized biotech and pharmaceutical companies can continue to build an eClinical strategy in today's economy in the autumn issue of the Journal for Clinical Studies.
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Medidata vice president and head of EMEA Steve Heath provides the editorial advisory keynote for the July issue of the Journal for Clinical Studies.
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Medidata vice president of implementation services Mukhtar Ahmed looks at the growth and challenges of the Asia Pacific region in European Pharmaceutical Contractor.
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Medidata senior client relations specialist Sondra Pepe provides an overview of the proposed Sunshine Act legislation and how pharmaceutical, biotechnology and medical device companies can prepare for the potential impact of these new federal requirements.
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Medidata explains how electronic protocol solutions can save time and costs for sponsors in eCliniqua.
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Medidata senior director of product marketing Ron Rubinstein and president of MonitorForHire.com Scott Freedman explain how EDC has changed clinical monitoring in VIEW on Clinical Operations.
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Medidata director of late phase solutions Patrick Chassaigne and vice president of quality assurance Fran Nolan explore how EDC can meet the regulatory challenges of post-approval research in the Good Clinical Practice Journal.
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Medidata director of late phase solutions Patrick Chassaigne explains how EDC can help power post-marketing studies in the Journal for Clinical Studies.
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Medidata general manager of Trial Planning Solutions Ed Seguine explains why it's time to change protocol design and how eProtocol will provide a radical shake-up of old processes and lead to improved productivity in International Clinical Trials.
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Medidata senior director of product marketing Ron Rubinstein offers three key ingredients to cost effective clinical system interoperability in Bio-IT World.
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Medidata senior vice president of development Keith Howells explores the opportunities, risks and technical requirements needed for an integrated EDC environment in IDrugs.
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Medidata head of EMEA Steve Heath takes a look at electronic data capture solutions in Next Generation Pharmaceuticals.
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Medidata vice president of knowledge management Daniel Mudgett and manager of knowledge management Ashwin Mundra discuss how integrated eLearning enables efficient and streamlined global trials in VIEW on E-Solutions.
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Medidata vice president of global operational excellence Doug Bain provides commentary on CDASH as the final piece in the end-to-end eClinical interoperability puzzle in Clinical Trials Today.
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Medidata vice president of integrations development Andrew Newbigging discusses how ePRO and EDC are perfect together in Applied Clinical Trials.
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Medidata's corporate compliance officer and vice president of global regulatory affairs & quality assurance Earl Hulihan provides a perspective on the FDA's updated guidance on the use of computer systems in clinical research in Applied Clinical Trials.
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Medidata general manager of trial planning solutions Ed Seguine discusses the efficiencies of EDC and eProtocols in View on Clinical Operations.
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Medidata executives explain how late phase studies benefit from EDC in Applied Clinical Trials.
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Podcasts
Global Biopharm Solutions president Steven Jacobs and Medidata director of Balance Solutions Ehsan Ramezani discuss the changes taking place in the clinical trial randomization and supply management arena, as well as the available solutions that appear to address the ongoing challenges in a Bio-IT World podcast.Listen
CEO & president of the Halloran Consulting Group Laurie Halloran and Medidata senior product director Steve Young discuss how clinical business analytics can help sponsors effectively mine the unprecedented amounts of data now available to clinical operations departments to make more informed decisions in a Bio-IT World podcast.
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Senior research fellow at the Tufts Center for the Study of Drug Development Ken Getz and Medidata vice president of data operations Lori Shields discuss how increasing trial complexity affects trial success, how to anticipate and manage trial hurdles and how to motivate trial progress through metrics in a Bio-IT World podcast.
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Medidata vice president of strategic regulatory initiatives Patricia Beers Block and senior product director Steve Young address questions on how today’s challenging environment is prompting study teams to explore the use of risk-based approaches to monitoring that do not compromise data quality. They discuss how limited resources can be directed more effectively to where they’re most needed and to the most critical review activities in a Bio-IT World podcast.
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Medidata vice president of quality assurance Fran Nolan and BLCMD Associates president Dr. Barton Cobert address drug safety regulation challenges that the biopharmaceutical industry is facing in clinical trials and the emerging new technologies that can help researchers address them in a Bio-IT World podcast.
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Medidata vice president of alliances Anne Zielinski and Monitor For Hire president Scott Freedman discuss how technology is altering the landscape for clinical monitors and impacting the success of clinical studies in a Bio-IT World podcast.
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Medidata president Glen de Vries and SAS global director of health and life sciences market segments Jason Burke discuss the current state of health business innovation, particularly around providing solutions for clinical trials and drug development in a Bio-IT World podcast.
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Senior research fellow at the Tufts Center for the Study of Drug Development Ken Getz and Medidata general manager of trial planning solutions Ed Seguine address the cause, not symptoms, of rising clinical trial delays and costs in a Bio-IT World podcast.
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Medidata and other industry thought leaders share the steps to shaping success in adaptive clinical trials in a Future Pharmaceuticals podcast.
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White Papers
Medidata's Approach to Today's Drug Development DilemmasToday's competitive biopharmaceutical environment demands a comprehensive integration of technologies that support the clinical development process. But companies are faced with many challenges and limitations imposed by commonly used clinical research point solution technologies. This white paper outlines how Medidata Solution’s approach is unifying clinical development and clinical trial execution through technology that addresses clinical research needs from trial concept to conclusion.
Using Technology to Deliver Complex Oncology Trials
Accelerating the outputs of clinical research, identifying sub-optimal treatments quickly and refocusing efforts on treatments that look more likely to succeed are pressing goals of oncology R&D organizations. This white paper explores how advanced technology available today offers the efficiency, speed and data visibility to help yield these results for research organizations.
Cloud Computing—Driving Security, Performance and Quality
This Medidata white paper explores how cloud computing drives specific regulatory and IT-security considerations in our industry that need to be correctly addressed, but also gives software providers such as Medidata the opportunity to offer customers products and services of a much higher quality and integrity than previously available to the industry.
Transforming Randomization and Trial Supply Management
A Medidata white paper presenting Medidata Balance and comparing its use and operation with other randomization and trial supply management (RTSM) methods.
Best Practice Clinical Trial Pricing Using Benchmark Data
A Medidata white paper examining the results of a survey and three case studies to provide insights on lowering the costs of clinical trials while still paying accurately.
Assessing the Impact of Protocol Design Changes on Clinical Trial Performance
A report in the American Journal of Therapeutics explores the results of a study conducted by the Tufts Center for the Study of Drug Development for simplifying protocol designs and minimizing negative effects on study conduct performance.
Racial Disparities Among Clinical Research Investigators
A report by the American Journal of Therapeutics detailing the underrepresentation of minority patients in clinical trials.
The eClinical Equation Part 1—Electronic Data Capture
An IBM white paper offers strategic insight on the EDC market and describes why after extensive investigations and analysis, IBM and Bayer unanimously agreed on the selection of Medidata Rave for Bayer's new EDC system.
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