Authors


Kate Wilson

Latest:

Understanding the Complexities of Diversifying Clinical Trials

Tufts Center for the Study of Drug Development and Biogen recently conducted a study to inform growing interest in improving diversity of clinical trial participation. The results of this research provide insights into increasing the community of minority investigators and study staff and presenting greater access to clinical trials among minority study volunteers.


Naomi Kautz

Latest:

The Rise of Gene Therapy: Advanced Regulatory, Site, and Enrollment Considerations

Developing new pathways to overcome study-related challenges is key to realizing the promise of the latest gene therapies.


Daniel Kavanagh, PhD, RAC

Latest:

A Biosafety Perspective on Operational Challenges in Cell and Gene Therapy Studies

The benefits of working with an institutional biosafety committee in CGT research.


Zak Smith

Latest:

Leveraging Data Insights to Address the Perils of Linear Practices in Site Identification and Activation

Phesi and Tufts CSDD share results from research on operating practices that can be improved.


Shana Hull

Latest:

Executing Trial Design With Patients—Not For Patients

Approaching protocol design and operational planning with patient empathy.


Juliana Ison

Latest:

Clinical Trials and Trust

Understanding the role of social determinants on clinical trial participation and trust.


Denise Dixon

Latest:

Virtual Medical Affairs Audits: A Viable Alternative

Virtual audits proving to be beneficial post-COVID despite continuing challenges.


Lisa LaLuna

Latest:

Introducing PALADIN

First-of-its-kind consortium dedicated to accelerating new medicines development through optimizing patient advocacy group—industry collaboration.



Susan Brisendine

Latest:

Patients Are at the Heart of Cell and Gene Therapy

If you are an organization content with patient-centric approaches, you are behind. Today it is about patient-driven drug development.


Robert Kerle

Latest:

The ICR-CRM-IQVIA Research Network Collaboration Experience

A discussion of the impact of a strategic alliance in to facilitate operational success at the clinical trial site level in Malaysia.


Ruby Madison Ford

Latest:

Assessing Sponsor Attitudes Toward Retail Pharmacy Involvement in Clinical Trial Recruitment and Execution

Amid CVS’ surprise exit from the clinical research space and the ensuing broader questions, study investigates the benefits of pharmacy chain involvement—along with the concerns and barriers to adoption.


Brian Ongioni

Latest:

Consent Management: Moving Beyond Simple eConsent

Providing patients with more flexibility in how they choose to participate in trials.


Ana Cosme, PhD

Latest:

Consequences of Brexit for Clinical Trials in Europe

Higher costs headline list of new challenges faced by CROs and sponsors.


Donna Hanson

Latest:

Optimizing Patient Recruitment and Engagement Strategies

Five strategies to reduce risk and achieve deadlines.


Priyanka Sawant

Latest:

Fast Track Implementation of eConsent: COVID-19 Paves the Way for Virtual Trials

As many countries slowly progress with the “New Normal,” researchers and healthcare providers are assessing digital/virtual approaches that could reinstate clinical trials.


Brian S. McGowan, PhD, FACEHP

Latest:

15 ‘Shades’ of Change in Clinical Trial Start-Up and Execution 

Embracing behavioral changes can lead clinical operations professionals toward driving meaningful outcomes.


Younes Benjeaa

Latest:

Gender Bias in the Clinical Evaluation of Drugs

Past decades have shown gender-based differences in clinical trial results are often overlooked when considering safety and effectiveness.


Bianca Piachaud-Moustakis

Latest:

Accelerating Clinical Trials in the EU

The ACT EU initiative aims to develop the European Union further as a competitive center for innovative clinical research.


KORE

Latest:

The Problem with Decentralized Clinical Trials and How to Solve for Success

Wed, Sep 7, 2022 11:00am EST | 8:00am PST | 4pm BST | 5:00pm CEST Decentralized Clinical Trials (DCT) is one of the hottest buzzwords in Life Sciences and Connected Health organizations today. Like any new approach, challenges and roadblocks are common and knowing how to solve for them will empower your organization to accelerate your trial deployment, speeding return of results and time to market.


Judy Narisi, RN, BSN

Latest:

Pitfalls to Avoid with Clinical Adjudication

Involvement of clinical endpoint committees in the adjudication process can improve reliability and robustness of data.


Jane Snowdon

Latest:

Characterizing Clinical Data Management Challenges and Their Impact

2020 Tufts CSDD – IBM Watson Health benchmarking study highlights need for new functionality from EDC solutions and providers.



Ping-Chung Chang

Latest:

‘Upskilling’ Your Workforce to Keep Pace with Change

The DCT-driven evolution requires new levels of understanding and expertise.


Stephen Raymond, PhD

Latest:

Considering Patient Burden in Oncology

Implementing new strategies with the use of patient-reported outcomes.


Robert Howie

Latest:

An Examination of the Role of the Clinical Research Associate and Factors Impacting Performance and Experience

Study by Tufts CSDD uncovers potential reasons behind CRA shortages, turnover, experience requirements, and more.


Alex Gee, Senior Director, Pricing & Market Access Parexel

Latest:

Four Key Trends for Identifying Regulator and Payer Evidence Needs in Oncology Drug Development

How to leverage novel trial designs and real-world data to support a cancer drug submission with an evidence strategy that is both approvable and reimbursable.



Patricia Dewaele

Latest:

Clinical Study Audits: The Quality Management Approach

Advancing risk-based auditing one step further by identifying the underlying process deficiencies to enable improved corrective and preventive actions.


Sarah Lyons

Latest:

Sharing Anonymized and Functionally Effective (SAFE) Data Standard for Safely Sharing Rich Clinical Trial Data

Presenting how data transformation is measured as part of the SAFE Data Standard, which data variables influence the rating and, how the appropriate level of data transformation is calculated.

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