Blogs

 Last month, Veeva Systems unveiled the results of its 2015 Paperless TMF Survey: Annual Report. The survey is in its second year, and as Jennifer Goldsmith, vice president of Veeva Vault, told Applied Clinical Trials, it was interesting and significant to report on the year-over-year results.

Forging new partnerships focused on the safety of long-acting opiates is important, as public health questions surrounding drug abuse and addiction have increased, along with regulations governing these products once they reach the market.

Merck & Co. Chief Medical Officer Dr. Michael Rosenblatt speaks with Applied Clinical Trials about the significant opportunities and challenges of sharing clinical trial data and the progress so far in developing a framework that, if properly pursued, could help transform the future of research and clinical care.

TrialReach is a patient recruitment/enrollment technology and service that uses machine learning algorithms, in combination with patient networks to get eligible patients to the right trials.

Nowhere has the advance of technology left its footprint more visibly than in the field of healthcare and clinical research.

The tone of agency’s annual report contrasts its recent candid stance on regulatory vision for Europe

The concept of increasing the speed and efficiency of clinical trials is a well understood and agreed upon priority of most clinical operations professionals.

 Engaging and recruiting participants for clinical trials continues to be a struggle for the life sciences industry. However, emerging technology partnerships in the biopharma space may be providing hope in accelerating patient enrollment and reducing bottlenecks through a concentrated focus on target profiles.

Recently, Applied Clinical Trials formed a Project Manager Committee, whose members will advise us on matters important for them to succeed in their positions

Many of us speak about the importance of clinical trial data quality and integrity, yet the lack of data quality standards and definitions introduces subjectivity risk in clinical trials.

Current clinical trials are regarded as “too slow, too expensive, not reliable, and not designed to answer the important questions,” according to FDA’s new deputy commissioner for medical products &tobacco, Robert Califf.

Type 2 diabetes mellitus is one of the Western world’s most common chronic conditions, with global prevalence increasing rapidly.

With the introduction of mobile health technologies in the field of healthcare, Sponsors and CROs are looking into mHealth to design patient centric clinical trials in order to reduce study visit costs and trial participation burden on patients.

Lexicon early on established an expanded access trial for those who screen-failed that would collect long-term safety data.

There is nothing more disappointing for a pharmaceutical company than to place its bets on a specific molecule/compound in its pipeline and invest billions of dollars in development, only to have the drug fail in late phase trials.

Among the multiple proposals for stimulating drug development and revising regulatory processes, the 21st Century Cures initiative includes several provisions designed to streamline clinical research and the amount of data required to gain FDA approval of certain indications.

In the debate over patient-centric considerations in cancer care, one main focus has been the choice of proper endpoints for clinical trials.

Demands from patient advocacy groups for broader subgroup representation in clinical trials has generated a new drug trial transparency initiative at the Center for Drug Evaluation and Research (CDER).

With the clinical trial industry’s focus on improving monitoring efficiency and leveraging a variety of risk-based monitoring (RbM) models, novel eClinical technologies are emerging to facilitate clinical trial monitoring productivity.

While some countries are more progressive in approaching this challenge by virtue of mandatory, free of charge, molecular testing on all patients, this varies greatly in other countries based on institutional policy and insurance reimbursement.

Understanding the roles of eTMF, CTMS, and study startup solutions in the clinical trials process

In a move designed to both tout the importance of precision and to improve the sponsor experience in conducting cardiac safety assessment, iCardiac Technologies announced a full risk-sharing program for Thorough QT studies.

Organized by country and topic area, the site also allows users to compare the requirements of two countries side-by-side.

Media rebuke of Europe’s Innovative Medicines Initiative thrusts debate into the public arena.

In yet another demonstration of how far drug pricing concerns are invading the hitherto sacrosanct territory of drug development, a consortium of national advisory bodies on pricing have written to the chief official responsible for European Union drug research.

“Never assume that something obvious is true,”

Biologic drugs and non-biologic complex drugs have revolutionized the treatment of many difficult-to-treat diseases including cancer, multiple sclerosis, and chronic iron deficiency.

FDA commissioner Margaret Hamburg has received praise and plaudits as she exits the Food and Drug Administration this week after six years on the job.