White Paper: Risk-Based Monitoring for Late-Phase Research

Risk-based Monitoring White Paper

A number of factors are leading to the paradigm shift in the way that clinical research is conducted. The increasing cost of research and the adoption of EDC technologies that provide real-time access to data have forced the industry to look at optimized methods of conducting clinical studies. In addition, several studies have shown that 100% SDV may not result in higher data quality. All of these factors have led to increased interest in RBM strategies.

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Risk-Based Monitoring for Late-Phase Research

Podcast: Risk-Based Monitoring for Late Phase: Implementation Strategies

Maria Harrison, Vice President, Late Phase Services, PRA

In this podcast, Maria Harrison discusses the past, present, and future of Risk-based Monitoring. She also covers challenges and solutions, as well as a real-life example of RBM in a clinical study.

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Risk-Based Monitoring for Late-Phase Research

White Paper: Pharmacovigilance in a Box

Improving pharmacovigilance decision making

While pharmacovigilance depends extensively on human sources for information input and processing of data, the growing volume of data and evolving regulations necessitates robust technology enabled process execution to manage the myriad of risks. This white paper covers the agile processes and robust technologies needed to provide vital scientific insights, process visibility and key trends for leaders to make real-time and proactive decisions.

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White Paper: Artificial Intelligence Tool Streamlines Drug Development

AI is Improving Drug Development

This white paper discusses how innovation will help us deliver on the promise of better medicines to patients sooner and more affordably. But technology and innovation must become flexible in order to do so, and to be flexible they must be extremely intelligent. Artificial intelligence for drug development is the future.

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White Paper: Racing for Results: Enhancing Your Performance Through the Use of Immersive Training Simulations

White Paper: Racing for Results

This white paper discusses how immersive simulations can improve the performance of the entire customer-facing organization, tightening the distribution of performance levels and reducing the variability of quality..

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Podcast: Immersive Learning: What You Need to Know to Build Faster, Smarter Commercial Teams

Garry O'Grady

In this episode, Mr. O'Grady speaks about immersive learning, what it is, and how it is the best choice for many types of mission-critical training.

Thought Leader:
Garry O'Grady, SVP and General Manager, Pharmaceutical Institute

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Racing for Results: Enhancing Your Performance Through the Use of Immersive Training Simulations

White Paper: Driving Innovation in BioPharma: From Discovery to Delivery with Product Lifecycle Management

White Paper: Innovation in BioPharma

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This white paper explores how product lifecycle management (PLM) can enable biopharma companies to develop innovative products that generate real economic benefits for their organizations and health benefits for patients.

Provided by: Kalypso

White Paper: Global Clinical Trial Data Collection: A minefield or a walk in the park?

Image by Chris Pearson

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Companies are losing clients and compromising their global clinical trials because the worldwide telephone numbers assigned to these trials are flawed. Participants and doctors calling to report critical trial data often cannot due to non-operational telephone numbers. The time and money spent to fix these faulty telephone numbers is costly, frustrating, and compromises the clinical trial and its success.

Provided by: Global Telecom Testing

Amped ATU: Free white paper How Data Fusion Can Turn Awareness, Trial, and Usage Studies Into a Powerful Tactical and Strategic Tool

Free white paper

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ATU studies can be turned into a powerful tactical and strategic tool by making them part of an integrated market research platform that includes a review of competitive promotional strategy, message recall and tracking, longitudinal patient data and prescription analysis, and benchmarking against normative data.

Provided by: Encuity Research

White Paper: Direct to Persona: The New DTC

DTC Marketing White Paper

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This whitepaper discusses the changes in Direct to Consumer marketing that are on the horizon. The old model worked for a while, but to thrive in DTC today a more social media marketing approach is needed. The new model is flexible, direct, and can be tracked in real time with. An integrated social media approach delivers better results with Direct to Persona marketing.

Provided by: Liquid Grids

Podcast: What is Creativity?

Anthony Rotolo

In this episode, Mr. Rotolo talks about creativity in the health and wellness space. We cover the importance of creativity in advertising, how to be creative, and, when used properly, how creativity influences behavior change.

Thought Leader:
Anthony Rotolo, Chief Creative Officer, True Health + Wellness

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Podcast: Developing Robust Potency Assays for Validation

Dr. Peter Wunderli

In this episode, Dr. Wunderli discusses PPD's recent laboratory facility expansion, outlines challenges and critical factors in cell-based bio bioassay product development, talks about disease states suitable for this type of technology, and finally, takes a look into the future of cell-based assays.

Thought Leader:
Peter Wunderli, Ph.D., Associate Director, Biopharmaceutical Services at PPD

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White Paper: Development and Qualification of Potency Assay Methods to Support Early Phase Release and Stability Testing of a Biotherapeutic Formulated with a Bioresorbable Carrier

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PPD's Cell Based Assay Laboratory was contracted by a client to improve the performance of a potency assay that had been developed for their biological product. The assay met pre-established qualification specifications for linearity, precision, and specificity and has been successfully implemented in testing the release and stability of multiple product lots, across an 18 month testing period.

Provided by: PPD

White Paper: New Challenges for Global Clinical Trials: Managing Supply Logistics in an Expanding Clinical Trial Universe

Global clinical trials require appropriate communication

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This white paper provides an overview of the New Challenges for Global Clinical Trials. The specific challenges discussed are the changing regulatory environment, customs requirements, infrastructure issues, data management, regional idosyncrasies, and differing quality standards.

Provided by: Fisher Clinical Services

Podcast: Value of a Credential in the Medical Publications Profession

Value of a CMPP Credential

In this episode, Stacy Simpson Logan talks about the value of obtaining a CMPP credential for employees and employers as well as the future of the CMPP program. CMPP stands for Certified Medical Publication Professional and is administered by ISMPP, the International Society for Medication Publication Professionals.

Thought Leader:
Stacy Simpson Logan, Chair, CMPP Board of Trustees President, Waterfall Consulting

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White Paper: Telehealth Solutions Enhance Health Outcomes and reduce Healthcare Costs

White paper: Can we enhance health outcomes with telehealth?

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This white paper provides an overview of what telehealth is, factors driving the healthcare industry to focus on increasing outcomes and reducing costs, how telehealth solutions can enhance health outcomes and reduce costs, benefits life science companies can expect from telehealth solutions, as well as results from two key studies of telehealth solutions.

Provided by: Tunstall Americas

Tunstall Americas

White Paper: Speaking Up for Speaker Programs

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Faced with increased regulation and limited access to physicians, pharmaceutical companies are using analytics to more strategically plan and invest in peer-to-peer programming. Here, Ogilvy Healthworld Marketing Analytics & Consulting investigates the key factors that result in increased prescribing behavior.

Provided by: Ogilvy CommonHealth Worldwide

Ogilvy Healthworld Marketing Analytics & Consulting

Podcast: Transitioning Clinical Trial Patients to Commercial Supply via Managed Access Programs

This podcast describes how Managed Access Programs can continue treatment access for patients coming out of registration or other clinical trials who need to transition to commercial supply.

Thought Leaders:

Suzanne Gagnon, MD, Chief Medical Officer, Idis
Karen Searle PhD, Study Director, Neuroscience & General Medicine (NGM), Eisai Global Clinical Development
Michelle Gee, PhD, Director, Neuroscience & General Medicine (NGM), Eisai Global Clinical Development

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Case Study - Continuing Access Post-Clinical Trial

Clinical phases through launch

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Idis designed and implemented a Managed Access Program that enabled trial participants to continue use of the drug prior to its commercial availability, taking resource burden away from the company. Read this case study for more information, including the results of the program.

Provided by: Idis

White Paper: 10 Questions on Developing and Marketing Therapies for the Aging Population

Marketing therapies for the aging population

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This white paper will address the critical questions for the industry and suggest prospective approaches that the industry can leverage as progressive companies target the enormous global emerging market that is older adults.

Provided by: Snowfish

Snowfish LLC