ARTICLES BY DÉBORA S. ARAUJO

• 7 Questions To Ask When Selecting A Site Payment Vendor

  2/27/2020

  The ability of clinical study sponsors to make investigator site payments accurately, on time, and with the appropriate level of details has long been an industry pain point. Sixty-six percent of investigator sites report having less than three months’ operating cash on hand, with lengthy delays in site payments resulting in high turnover rates among clinical investigators.

• 6 Rules For Establishing Bulletproof CRO Governance

  12/23/2019

  With the increase in strategic partnerships and alliances between pharmaceutical or biotech clinical study sponsors and contract research organizations (CROs) sweeping the clinical trials industry, study sponsors often see a need to establish formal structures to help guide these relationships. This, many times, will come in the form of a CRO governance structure. And, of course, the need is not only to establish CRO governance but also to make it effective. Although each organization and relationship is unique, there are a few critical rules that can greatly increase the chance that this governance will be effective. Before exploring these rules, let’s review some foundations of CRO governance.

• 3 Critical Areas To Review In Strategic Site Selection

  8/8/2019

  Have you ever put off doing something you knew needed to be done, even though you had the ability and money for it?  Think exercising, getting a will or going to the dentist (hopefully you have dealt with at least the latter).  In the same way, many study sponsors put off aggregating and utilizing key intelligence on their previously used investigator sites for use in future strategic site selections. At times, there will be unique reasons for engaging with a certain investigator site or the need to use research-naive sites. However, if previously used sites will be considered for a new study, it is vital to review some key information for a truly strategic site selection process.  Let's take a look at some of these key, yet often forgotten, areas.

• Measuring The Financial Impact Of Remote (Digital) Clinical Trials

  1/29/2019

  Many companies are exploring ways to continue to innovate and bring novel drugs to patients while reducing the overall costs of drug development process. Enter… remote clinical trials.

• Do Your Clinical Trials Suffer From Adoptaphobia Syndrome?

  1/25/2018

  Despite the focus on innovation at conferences, TED talks, and other forums in the last few years, as an industry we are still very slow to innovate and even slower to adopt new technologies, best practices, and methods.  This intense fear of adoption in our industry is what I affectionately call “adoptaphobia.” Adoptaphobia refers to our industry’s fear of and reluctance to adopting new initiatives, best practices, and technologies to create efficiencies and reduce redundancies.  We love to talk about issues and deliberate and discuss new methods, but we are extremely slow to commit and adopt the recommendations and methods that we agree would make everyone’s lives easier and streamline the process.

• 7 Ways Remote Clinical Trials Will Impact Investigator Site Budgets

  8/3/2017

  With the age of remote clinical trials upon us, it bears asking: What do these trials mean for the common business-related tasks of clinical trials? One under-emphasized place of change will likely be investigator site budgets.

• 4 Villains That Can Delay Your Clinical Trial Agreement (CTA) And How To Defeat Them

  4/12/2017

  Imagine for a moment you are your favorite superhero, charged with the task of saving the whole world from villains such as the Joker, Lex Luthor, Doctor Doom, and the Green Goblin. You would not be very effective — or much of a superhero, for that matter — if you only took one of them out while letting the others roam free. In the same way, as an industry, we cannot effectively tackle the issue of delays in the execution of Clinical Trial Agreements (CTAs) by only addressing one or two of the “villains” contributing to this industrywide problem. 

• The 4 Biggest Investigator Site Payment Issues — And How To Solve Them

  3/15/2017

  Imagine that after a tedious job interview process you are finally offered what promises to be a fulfilling and rewarding position with a new company. However, after working there for a while, you notice that the employer is only really paying you every three to six months, which has made it difficult to keep up with your bills and to stay financially afloat. You also notice that when you do receive a check from the employer, you have no way of verifying for which days or hours you have been paid since no explanation is sent with the check and you were never told who at the company you could contact for these types of questions.