Thought Leadership

Thought Leadership

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The Vendor Oversight Checklist

Whether you are new to vendor management or a seasoned pro, we all need a set of fundamentals as a foundation. This Vendor Oversight Checklist will serve as a healthy "gut check" for your vendor collaboration relationships. The list includes some additional TMF pro tips if your vendors are helping support your TMF management.

Summary, Critical Details, and FAQ for Your TMF Management

European Medicine Agency (EMA) Guideline on the content, management, and archiving of the clinical Trial Master File (paper and/or electronic), effective 30 June 2019

Mobile eTMF: Once a “Would-Be-Nice”. Now a “Must-Have”!

While there will always be a debate about when, where, and how much time people should spend on their phones, there is no debate to be had about how easy they can make accessing information and accomplishing tasks on the go.

MHRA’s GCP Findings: It’s About Oversight

A well-managed eTMF saves time, money, and reduces risk. As a life sciences company, reducing clinical trial costs while accelerating processes and eliminating inspection findings is music to the ears!

LMS: A Must for Study Compliance & Efficiency

Choosing the right Learning Management System (LMS), will not only help you save time and money, but it can help with an approach to learning that is best-fit for compliant-focused organizations. Effectively trained study teams are better equipped to run compliant studies.

GVP and Literature Monitoring in a Global World

White Paper - TransPerfect Life Sciences

Here's to Your eTMF Health

Michael Smyth explores best practices for measuring KPIs with some examples of performance metrics and documentation.

Best Practices for Achieving TMF Quality

Donna Dorozinsky, President of DWD & Associates explores the latest TMF best practices and outlines how e-clinical solutions can be employed to streamline clinical processes and prepare for inspection readiness.

Assessing Efficacy of Our Life Saving Drugs

Presented at the 18th DIA Annual Workshop in Tokyo, Japan, Narreh Ghazarians, Life Sciences Solutions Project Manager, discusses the use of a single electronic platform to manage all aspects of endpoint adjudication to improve efficiency and timelines, resulting in substantial cost saving.

eTMF & Site Archiving: Perspective, Case Studies, Lessons Learned

Presented at the 4th TMF Summit in Arllington, VA, Shannon Cooke, Life Sciences Solutions Manager, discusses the EDM and eTMF Guidelines, challenges to move from paper to electronic eTMF filing, and integrated platform that connects feasibility, study start-up and eTMF.

How to Streamline Your Global Pharmacovigilance Management Process While Reducing Costs

Over the past 20 years, the pharmaceutical industry has undergone a radical shift. Due to frequent mergers and acquisitions, the number of large pharmaceutical companies has shrunk significantly. At the same time, the pool of smaller companies that develop products has grown. Read further to discover how to streamline the global pharmacovigilance management process while reducing costs.

Paperless Clinical Trials: How and Why

Presented at MAGI East, Shannon Cooke, Project Manager, discusses the benefits of paperless clinical trials and the most efficient ways to make the shift from a paper-based system.

A "Holistic" e-Clinical System: Be Wary of Managing Clinical Development with Blinders On

Many challenges in pushing towards digitization of clinical information have not been addressed. The main reason for this lack of development can be attributed to trial sponsors reapplying the same processes they use with paper documents to electronic documents. Learn more about these inefficiencies and proposed enhancements to clinical platforms.

Leveraging Clinical Data to Streamline Global Development

Presented at CBI's ClinTech, Vladimir Pyagay, eClinical Solutions Engineer, discusses how to leverage clinical data to streamline global development for maximum efficiency.

4 Ways You Can Overcome Roadblocks to Technology Adoption in Clinical Trials

Take a look at why companies resist the move to a paperless environment, and why these roadblocks should be eliminated as quickly as possible so as to decrease cost and increase efficiency across all clinical trials.

An Introduction to the Pharmacovigilance System Master File

Presented at Arena's Pharmacovigilance, Drug Safety and Risk Management Conference, Scott McCulloch, Director of Business Development, discusses the Pharmacovigilance System Master File and how to properly implement it in today's industry.

The Correlation between Patient Reported Outcomes and Clinical Reported Outcomes

Presented at ISPOR Dublin, Becca Dawsey, Director, Strategic Accounts, teamed with Quintiles Outcome and Roche Ltd to discuss the degree of correlation between patient reported outcomes and clinical reported outcomes and how these vary.

Mid-Study Transition of a Global Study: Migration from Paper TMF to eTMF

Presented at ExL's European Trial Master File Summit, Ashley Smith, Project Manager, discusses a case study on a major pharmaceutical company conducting a study in 30 different countries.

Running A Paperless Clinical Trial: From Start to Finish

Presented at MAGI West, Shannon Cooke, Project Manager, TransPerfect and Eric Levie, Chief Technology Officer, Clinical Research Advantage discuss the efficiencies of conducting a paperless clinical trial.

Paperless Clinical Trial Optimization – Thinking Outside the Box

The implementation of best practices for clinical study and development conduct can streamline administrative burdens for investigator staff as well as study teams, and hopefully yield reduced costs in conducting global clinical development.

eTMF: Yes, Virginia, Paper is Disappearing

The noise around eTMF is a signal that change is imminent. Sponsors are increasingly struggling with eTMF, as are the CROs who need to either use the sponsor's eTMF or provide one for the sponsor to use. Executives at CRO Worldwide Clinical Trials share their discrepancies with using a paper-based system and plans for a paperless future.

Resourceful Resourcing: Consolidate Your Technology Providers

The tenets of clinical development for the modern life sciences industry have been unchanged for decades: we are in pursuit of developing products faster and more cost effectively while retaining efficacious, high quality data with a watchful eye on patient safety. Learn how Michael Smyth discusses the ongoing challenge of consolidating technology providers in today's industry and how to embrace this dynamic.

Engage with Patients, Not Paper

Michael Smyth, General Manager, Life Sciences Solutions, discusses the use of technology at clinical investigative sites with Clinical Leader Editor, Ed Miseta. Learn how the shift to electronic documents is changing the life sciences industry and the challenges with paper that lie ahead.

Freeing up Investigators' Time to Engage with Patients

Presented at a DIA Conference, General Manager of TransPerfect's Life Sciences Solutions, Michael Smyth, discusses investigative site challenges when conducting a clinical trial and how to overcome them.

Global Call Centers for Life Sciences Organizations

With many pharmaceutical and biotechnology companies now conducting their clinical trials in emerging markets, the need for multilingual communication methods has grown. Myriad risks are associated when conducting clinical trials that are not in investigator's native language. Learn how multilingual call centers affect clinical development and what to look for in a call center provider.

Experience with eTMF and Site Archiving

Presented at a DIA Conference, General Manager of TransPerfect's Life Sciences Solutions, Michael Smyth, discusses how the use of electronic Trial Master Files can accelerate the clinical trial process and life sciences industry as a whole.

The Path of Resistance

Facing the conundrum of how to reduce paper cost, use and storage in clinical research? Michael Smyth, General Manager of TransPerfect's Life Sciences Solutions, explains what to look for in today's electronic data capture environment.

Moving Towards an Electronic Environment International Clinical Trials

With each passing year, clinical trials are becoming increasingly global. The business of product development is moving away from the traditional model in which studies are conducted primarily in the US. This article will highlight some of the necessities for companies looking to compete in the clinical development marketplace.

FDAAA: Considerations to Limit Expenditures in Postmarketing Research

This article highlights some of the key features of post approval research, and offers some best practices for creating operational efficiencies that will help biopharmaceutical companies reduce the impact of this regulation and limit the resulting increased expenditures.

Consolidating Your Language Outsourcing for Global Clinical Development: A Roadmap from End-to-End

As more clinical trials are being conducted internationally, and the clinical development world becomes increasingly globally dispersed, it also becomes more competitive. Those companies who take a measured and consolidated approach to global communications will earn an edge in a number of areas, including consistency, cost, risk management, and regulatory review.