Authors


Matthew Noble

Latest:

Bring Your Own Device for Trial Outcome Assessment

Survey uncovers the challenges, myths, and potential useful strategies associated with BYOD adoption.


Jeff Lee

Latest:

Patient Engagement Surveys in Clinical Trials: Dos, Don’ts and How They Help

This article will address concerns and look at how the pragmatic implementation of surveys in today’s clinical trials can provide valuable insight into patient satisfaction levels, motivators, likelihood to follow study requirements and information retention.


Willie Muehlhausen

Latest:

Taking eCOA Delivery Off the Critical Path to First Patient In

Streamlining electronic clinical outcome assessment and patient-reported outcome processes can aid in decreasing timelines.


Emma Beausang, PhD

Latest:

Where’s the Exit? An Update on Brexit

With the U.K. poised to begin the process of leaving the European Union soon, many questions remain as to the specifics of pharma regulation and the wide-ranging effects of this departure.


Philip Coran

Latest:

How Do iComply? Regulatory Topics Surrounding mHealth in Clinical Trials

Outlining several critical areas of regulatory oversight that clinical trial researchers need to consider when using mHealth technologies.


Dr. Andrew Rut

Latest:

Digital Transformation of SAE Data Capture in Clinical Studies

Processes for collecting data of serious adverse events (SAEs) and events of special interest (ESI) during clinical trials have been underwhelming for sponsors. Improving these processes using the latest digital advances can result in more complete analyses and more effective decision-making.


Donald Cooper

Latest:

Future Directions of Cancer Immunotherapy in Clinical Trials

Progress and innovation within oncology has accelerated to a paradigm that includes immunotherapy and bio-genomics. Collaborative approaches in the future will continue to transform treatments in hopes of improving patient quality of life.


Elizabeth S. Ronald

Latest:

Archiving Approach in the UK

The proper storage of research documents remains an essential aspect of the clinical trials process.


Simon Francis

Latest:

Partnering with Patients: Clinical Trial Retention and Engagement through Patient Data Return

How sharing patient data drives trial engagement and honors patient contributions to the research process.


Shalleen Barendse

Latest:

The FDA's Guidance on PRO

This guidance has both raised the stakes and improved the odds of securing label claims based on PROs.


Robert Lins, MD

Latest:

Early Phase Pharmacodynamic Models for Respiratory Drug Candidates

Respiratory disease trials are difficult to initiate, both in terms of patient recruitment and accurately collecting data. Alternative methods are required to improve outcomes and develop new treatments for respiratory diseases.


Elizabeth P. Tolmie

Latest:

Archiving Approach in the UK

The proper storage of research documents remains an essential aspect of the clinical trials process.


Sara M. Pressel

Latest:

Exploring the Role of the Regional Coordinator

How one large academic trial adopted a coordinating center model-helping drive early-model RBM gains


Janice M. Johnson, SMC

Latest:

Exploring the Role of the Regional Coordinator

How one large academic trial adopted a coordinating center model-helping drive early-model RBM gains


Lillian Carroll

Latest:

Exploring the Role of the Regional Coordinator

How one large academic trial adopted a coordinating center model-helping drive early-model RBM gains


Connie Kingry

Latest:

Exploring the Role of the Regional Coordinator

How one large academic trial adopted a coordinating center model-helping drive early-model RBM gains


Jeanne Hecht

Latest:

The Evolution of CRAACO: Gains and Lessons Learned

Tracking efforts to advance the mission and concept of "clinical research as a care option."


Nicola Goatman

Latest:

Clinical Trials Status in BRIC

With North America and Europe accounting for the majority of active clinical trial sites in 2016, the need for globalization is increasing. Brazil, Russia, India and China are emerging markets with potential, but not without challenges.


Michael Towse

Latest:

Medical Device Body of Knowledge Training Strategy

To provide more targeted training and validate understanding to employees, it is important to establish baseline knowledge. This case study explores how Chiltern developed its Medical Device Body of Knowledge training program.


Eric Morrie

Latest:

Clinical Trial Design & Management: Best Practices for Small Budget Studies

ClinCapture hosts a panel discussion with experts from CROs and sponsor companies to discuss conducting quality clinical trials in a cost effective manner.


Edmundo Muniz, MD, PhD

Latest:

Drug Development through Modeling and Simulation - the Business Case

The drug development process has been seen as inefficient and disappointing by those in the R&D space. Model and Simulation provides a potential relief to these issues by delivering significant business, scientific and clinical value to drug developers.


E.M. Kolassa, MBA, PhD

Latest:

Drug Development through Modeling and Simulation - the Business Case

The drug development process has been seen as inefficient and disappointing by those in the R&D space. Model and Simulation provides a potential relief to these issues by delivering significant business, scientific and clinical value to drug developers.


Clare Grace, PhD

Latest:

Be Part of the Movement

Despite the increasing number of clinical trials in the United States, still participation remains at an all-time low. You can make a difference with participation in INC Research and CISCRP’s “Inspiring Hope’ Ideathon by submitting ideas to increase clinical research awareness.



Denise Calaprice, PhD

Latest:

Accelerating Innovation Adoption to Support Drug Development Operations

Characterizing the long-term adoption experience of clinical technologies and capabilities—and what senior leaders can do to drive adoption within their walls.


Mitchell Katz, PhD

Latest:

Lean Outsourcing Models for Clinical Trials, Part 2: Optimizing Technology

A key success factor for lean models is the possession of technology that can measure performance and manage risk in a well-organized and user-friendly manner. This article describes the results of an investigation to identify and describe the basic requirements for such technology solutions.


Ranjana Chakravarthy

Latest:

New Benchmarks for Trial Initiation Activities

Assessing practices and inefficiencies with site selection, study start-up, and site activation.


Hilde Vanaken, PhD

Latest:

eConsent is Not What You Think

Harmonization and value insights are fundamental to bring eConsent to the place it deserves.


Lesley Schofield

Latest:

Patient Centric MS Trial Results

A patient-centric approach to a Phase IV trial for an MS treatment resulted in lessons that can be applied to future therapeutic studies for this and other rare diseases.


Nancy Mulligan

Latest:

Patient Centric MS Trial Results

A patient-centric approach to a Phase IV trial for an MS treatment resulted in lessons that can be applied to future therapeutic studies for this and other rare diseases.

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