Authors


Tufts, CSDD

Latest:

Competitive Pressure for First-in-Class Drugs is Intensifying

Study shows sharp reduction in market exclusivity periods for first-in-class treatment entrants.


Medidata Solutions

Latest:

Modernizing Data Management in the D-Clinical Age

***Live: December 9, 2020, at 11am EST| 8am PST| 4pm GMT| 5pm CET*** In this ‘D-Clinical Age’, leveraging modern technologies and new approaches and mind sets is required to accelerate the development of new treatments. This webinar will examine how data management can drive digital transformation with the right mix of technology, skills and process redesign.***On demand available after airing until Dec. 9, 2021.***


Rajnikanth Madabushi

Latest:

PK in Late Phase Trials

Collecting PK data in late phase trials led to alleviating additional trials, drug approval, and better dosing.


Carsten Brockmeyer

Latest:

Developing Quality Biosimilars

Biosimilars are a steadily growing new field of biopharmaceutical development and clinical research.


Vera Pomerantseva

Latest:

Data Management Efficiencies Through Risk-Based Approaches and Innovations

Because of drastic changes in the clinical trial space, there is a need for advancing and streamlining design through risk-based methodologies and innovations.


Mark Nixon

Latest:

Drivers of Patient Interest in Referral

Analysis suggests age, condition, and treatment satisfaction have most significant effect on participation.


John F. Tomera

Latest:

Enrollment: More Than Numbers

Partnering with CROs and using a blinded independent central review can increase trial success.


Blair Keagy, MD

Latest:

Medical Device Trials

Understanding the United States' regulatory pathways and clinical operations.


Marylyn Donahue

Latest:

3 Ps Of Personal Trial Negotiation: An Expert Shares His Secrets

For each clinical trial, a clinical trial agreement and budget are negotiated between the investigator and the sponsoring company so that the costs of carrying out the trial are reimbursed.


Jeffry Florian

Latest:

PK in Late Phase Trials

Collecting PK data in late phase trials led to alleviating additional trials, drug approval, and better dosing.


Luis Archila

Latest:

Emerging Opportunity in Guatemala

Guatemala is multi-ethnic, multilingual, and multi-cultural-ideal for international trials.


Keith Meadows

Latest:

ePRO in Diabetes Studies

Conversion from paper to ePRO for an instrument designed to assess diabetes' impact on quality of life.


Margo Michaels, MPH, ENACCT

Latest:

Making a Difference in Cancer Trials Accrual

The integration of pre-screening all patients for eligibility in oncology studies.


Fang Li

Latest:

PK in Late Phase Trials

Collecting PK data in late phase trials led to alleviating additional trials, drug approval, and better dosing.


Kathleen Zajd

Latest:

Early Phase Trials

Optimizing early phase trials key to the success of novel cytotoxics and targeted therapies.


Christine Blazynski, Ph.D.

Latest:

Hidden Successes of Oncology Trial Terminations

Current trends in oncology trial terminations as analyzed by Citeline have revealed that sponsors are learning from the past and making gains in this troubled area of drug development.



Fred Gebhart

Latest:

New Technologies Close the Recruitment Gap

A growing number of providers are adapting 21st century web-based and mobile tools to connect the corners, boost trial participation, and speed trial completion.



Stephen McClanahan

Latest:

Emerging Opportunity in Guatemala

Guatemala is multi-ethnic, multilingual, and multi-cultural-ideal for international trials.


Jeff Parke

Latest:

Blockchain Use in Research

The core tenets of blockchain technology-a decentralized and encrypted way of distributing, sharing, and storing information-seem appealing for health data.


Phuong Tran

Latest:

Are Phase III Clinical Trials Really Consistently Behind Schedule?

With a unique business model, pharmaceutical companies and their subcontractors need to find every way possible to shorten drug development times consistent with patient safety. The challenges facing commercially oriented organizations developing prescription drugs are substantial.


Thermo Fisher Scientific

Latest:

Panel Discussion: Merck R&D’s Digitally-Enabled Clinical Trial Team

***Tuesday, January 12, 2021 at 11am EST | 8am PST | 4pm GMT | 5pm CET***Merck’s Digitally-Enabled Clinical Trial Initiative Members or “Smart Team” will discuss their experiences introducing digital technologies into the clinical trial paradigm and within their function. *** On demand available after final airing until Jan. 12, 2021 ***


Christoffer W. Tornoe

Latest:

PK in Late Phase Trials

Collecting PK data in late phase trials led to alleviating additional trials, drug approval, and better dosing.


Raul Barrera, MD

Latest:

Emerging Opportunity in Guatemala

Guatemala is multi-ethnic, multilingual, and multi-cultural-ideal for international trials.


Gillian Woollett

Latest:

Developing Quality Biosimilars

Biosimilars are a steadily growing new field of biopharmaceutical development and clinical research.


Ken Phelps

Latest:

Using 505(b)(2) to Solve Shortfall from Generic Cliff

Understanding the benefits of this application route in helping companies withstand the hit of patent expiries.


Christine Garnett

Latest:

PK in Late Phase Trials

Collecting PK data in late phase trials led to alleviating additional trials, drug approval, and better dosing.


John McCarthy

Latest:

The Virtual Organization: Is It the Future Industry Landscape?

Outsourcing and data-sharing technologies are creating virtual pharmaceutical companies. Soon, you may be only as good as your network.


Hao Zhu

Latest:

PK in Late Phase Trials

Collecting PK data in late phase trials led to alleviating additional trials, drug approval, and better dosing.

© 2024 MJH Life Sciences

All rights reserved.