Columns | A Closing Thought

Demonstrating biosimilarity is highly dependent on the unique characteristics of the product.

Quality is not just a way to gratify sponsors or authorities, but should be part an established and dynamic QMS.

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

A well designed CTCP can keep everyone motivated and focused on achieving trial objectives.

The adoption of new, consistent definitions are needed to help demystify late phase trials.

Researchers who work on HIV vaccines face a major challenge: convincing members of at-risk communities to volunteer for these trials.

Choosing eClinical solutions can appear to be a tricky situation.

All measurements and outcomes need to reflect what is happening with the patient.

While risk and uncertainty remain high, the pace of innovation will remain glacial.

BRIC governements are working to make it easier to conduct trials in country.

Drug, biological supply, and medical device manufacturers must track all payments of over $10.

While order might be useful for smaller firms to do business, it is not useful in helping them to innovate.

Knowledge is power, but power is of no value if you don't exercise it.

Potential patients entering any trial need to be informed citizens able to understand and assert their rights.

Transfer of material between the supply cahins can be time consuming and complicated

Medicine is not quantum mechanics where we cannot predict when an event will occur

Better access to information vastly improves the decision-making process.

Inappropriate calendar pacakaging is a common occurrence leading to confusion and mistakes.

The guidance has driven the industry to take note of the patient-to listen, understand, and document.

Until the late 80's, Phase III trials were conducted essentially in North America and/or Europe.

eC-SSRS can serve as an effective approach to meeting the pending FDA regulations.

The act creates serious concerns about the industry's ability to recruit and retain well-qualified investigators.

There is increasing recognition of the need to understand product safety in the real world.

FDA is saying that a study coordinator "generally" performs critical functions, such as subject recruitment.

The 12-year data exclusivity period has significant implications in delaying the launch of biosimilars.

The 12-year data exclusivity period has significant implications in delaying the launch of biosimilars.

There is still an endemic inefficiency in health care and clinical trial record connectivity.

Whether companies participate or idly observe community activity, this is a tactic worth considering.

How different can the health care environments be from where data is derived to justify pooling?

Through digital signage, sponsors hope to increase enrollment in trials.