Resource Management: To Algorithm or Not to Algorithm?

Demand forecasting—the ability to project demand by role and project—is an important part of resource management. Companies conduct demand forecasting in several ways. Some have project managers enter demand by role for, say, 12 months. Others communicate standards to help drive consistency in how project managers estimate demand. Still, others create demand forecasting algorithms to[…]

Inside Investigator Meetings (Part 4 – The Root of the Matter)

Regardless of how one looks at the current state of investigator meetings, there is no question there is room for improvement. Like any improvement initiative, the first question the sponsor needs to ask is, “How does this benefit the bottom line?” The value of an investigator meeting needs to be properly defined and evaluated. Any subsequent[…]

Case Report Form Training

Case Report Forms.  In the world of clinical research, these forms are the basis for marketing approval.  Well-designed, they can foster faster, better and more accurate completion.  But be it paper-based or electronic, training users to use them can be a challenge. Even if trained correctly, there are often a series of delays from after[…]

Clinical Investigator Training and Site Staff’s Transcripts

Clinical investigator training as well as site personnel training has been part of the clinical research process for well over a decade now.  However, site personnel are constantly forced to retake training. This is because sponsors often do not recognize, nor do they have access to, completion credit for a given course or topic. This problem[…]

SOP Training for Clinical Research – Can it be Fun?

The mere mention of SOP training can make even the veterans among us shudder. But does it really have to be this way?  Does compliance training really differ from any other training?  Shouldn’t we apply the same principles of instructional design?  Does it always have to be the dull, boring, uninteresting, and monotonous “check here[…]

Inside Investigator Meetings (Part 3 – The Survey)

In previous blogs, I mentioned issues mentioned with regards to collecting feedback via surveys. However, I was able to collect a significant amount of data from attendees at various investigator meetings (21 in total, all Phase III studies). I used two different sets of standardized surveys throughout: internal (sponsor focused) and external (site focused). At the end of[…]

Inside Investigator Meetings (Part 2 – The Bad)

As mentioned in Part 1 of this blog series, 78% of respondents in the CenterWatch Monthly survey rated the overall usefulness of investigator meetings as “Good” or “Excellent.” But how does one define usefulness? To whom is the meeting useful and for what reason? According to one of the respondents, “The networking is, frankly, the only[…]

Inside Investigator Meetings (Part 1 – The Good)

Nowadays, conducting a clinical study is more complicated than ever. Clinical studies have more complex protocols, new technologies, and increased regulatory scrutiny. It has made study execution more challenging. Regardless of the rise in difficulty, what matters is that a sponsor collects good, clean data that reflect how well its drug works. This increased difficulty raises[…]