Investigative Sites

On Wednesday, DrugDev is debuting its Site Activation Module at the SCOPE Summit. The company believes the module will greatly improve all tasks of site activation, from protocol feasibility, site identification and selection, to contracts and the collection of site regulatory documents.

While several studies and surveys have examined the relationship between sponsors and CROs, there has been little analysis of CRO-investigative site relationships. This study uncovers useful learnings on the positive and negative experiences of investigators in their direct dealings with CROs.

Clinical Ink, an eSource solutions provider, offered Applied Clinical Trials raw data from its Site Impact Survey for analysis. This article will delve into this data to uncover breakthrough trends regarding the utilization of eSource on workload reduction at study sites.

Survey of pharma and CRO clinical trial professionals attempts to answer whether Eastern European countries are still considered attractive destinations for clinical research.

This article will describe my experiences in acquiring new clinical trials from the study site’s standpoint.

Study takes rare look at the financial and resource burden for sites in managing regulatory compliance.

Do 50% of US investigators only conduct one clinical trial? Much of the misunderstanding behind this “one time” claim, which first surfaced in the 1990s, rests on a misunderstanding of the BMIS.

Building a structure for managing study operations through linking trial- and site-level forecasting.

Over the past several years, there has been a rise in nonprofit organizations that focus on addressing the challenges in clinical research.

The sharp rise in ongoing clinical research studies is driving demand for greater participation in research by physicians as well as by patients.1

The organization of healthcare is changing rapidly. The healthcare delivery system is increasingly powered by payers and regulators, and this directs both clinical medicine and drug development. Partly because of this change, the drug development process has been heavily scrutinized, and a great emphasis has been placed on more efficient translation of basic science into useful medicines.

After a five-year review of clinical trial quality measurement research and practices, we have concluded that clinical trial quality measurement does not meet current scientific standards

Patient enrollment for clinical trials is not a numbers game.

Sponsor-site alignment on risk-based approaches is critical if clinical trial standards are to reach new levels.

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

The next 18 to 24 months may bring profound changes for investigative sites.

Asia Pacific and US physicians' attitudes toward involvement in clinical trials.

Prior to initiating a trial with ED sites, three factors must be considered in order to achieve success.

Sponsors, CROs, and investigator sites must all work together for effective patient recruitment.

A 10-fold reduction in LTFU rates was observed in clinical trials that used patient tracking services.

Research sponsors and the research community must solve the inefficiency and redundancy that plagues the ethics review system.

Why are some contract research organizations, sponsors, and other research facilities not pursuing accreditation?

Navigating state and local laws and protecting the rights of human subjects are two of the many benefits of independent IRBs.

Registration is required for FDA-regulated IND studies, but is it needed for non-IND studies?

Monitoring of clinical trials is a federally mandated responsibility of trial sponsors and a core offering of contract research organizations (CROs) that is crucial to the validity of clinical research.