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Why do we audit our suppliers and what do we hope to achieve when we do?

It should suffice to say that obtaining informed consent is required ethically and legally in almost all forms of human research in almost all countries.

Implementing a "just-in-time" site activation process effectively can significantly speed trial startup.

As the biopharmaceutical industry continues to move down an outsourcing path, it is essential that logical sourcing strategies and operational processes exists and align with corporate strategy.

Pharmaceutical sponsors conducting clinical trials in the Asia Pacific region have a rare opportunity at hand...

The patent cliff that rocked big pharma is now starting to reverberate in companies developing generic alternatives.

More attention is being paid to blood pressure effects in new chemical entities under development for non-hypertension indications.

Why the requirement for the collection of cardiac safety data?

In the clinical development setting, most organizations are already working in an electronic world but still thinking in "paper."

The costs of drug development are increasing, driven in large part by increasing failure rates in all phases of clinical development.

With the public release of physician payment data slated for September, the implications for medical and scientific communications are many.

The potential of comparative effective research in transforming healthcare remains untapped, but the opportunities are there.

As a principal investigator in the early 1980s at University Hospital in Peru, I used to receive instructions and queries from the study team through a Telex machine.

Medicines development and clinical research are among the most heavily regulated activities on a global basis.

Kenneth Getz spoke to Applied Clinical Trials about his book, as well as the changes in clinical trials since the first edition.

Most business leaders acknowledge the pitfalls of organizational silos: they breed inefficiency and signal systemic malfunctioning.

With the rationale of making Europe a better environment for clinical research, the European Union is taking steps towards greater transparency of clinical trial data.

The advent of Risk Based Monitoring will change the traditional Clinical Study Monitor’s (Monitor) role significantly.

Linking Leaders, host of invitation-only roundtable forums for clinical trial executives, has witnessed the rapid advancement of quality approaches supporting modern clinical trials.

Clinical trials often fail to reach desired goals due to poor recruitment outcomes, including low participant turnout, high recruitment cost, or poor representation of minorities.

Competitiveness in the field of industry-sponsored clinical research is largely contingent on speed, quality, and cost.

Organizations involved in clinical trials have embraced the idea that they should collect performance measures to assess how well they conduct clinical trials.

Identification, reporting, and evaluation of protocol violations during a clinical trial is integral in adding value to the study data.

How does one determine and define the "risk" in a risk-based monitoring approach for clinical trials?

There is a similar trend in healthcare and clinical research: finding ways to better connect patients with the medical services and therapies they need at exactly the right time.

Eight million people in the US alone suffer from chronic stable angina, the chest pain and tightness associated with myocardial ischemia caused by coronary artery disease

As the pharmaceutical industry continues to face increasing cost of drug development, sample banking for future clinical research provides the pharmaceutical industry with new opportunities to obtain biological sample collections that will allow it to investigate safety and efficacy in future clinical research and answer regulatory authority questions related to safety and efficacy at the time of registration.

Today's pharmaceutical industry faces many challenges as drug development costs continue to climb, pricing pressures mount, and new global markets gain critical importance.

The specialized industry of collecting patient-driven eData is increasing exponentially. Patient-driven eData encompasses all electronic clinical outcome assessments - or eCOAs -- including patient reported (PRO), clinician reported (ClinRO) and observer or caregiver reported outcomes (ObsRO).

Before the Orphan Drug Act of 1983 the FDA and lawmakers considered designation and incentives for orphan development without much consideration for competitors in the same orphan space.