Chris Pagotto

Driven by the demand to bring drugs to market faster, pharmaceutical companies have fully embraced technology in all its glory. Further driving this acceptance is the encouragement of the FDA to submit investigational new drugs (INDs), new drug applications (NDAs), and regulatory submissions electronically. In fact, this will likely be mandatory in the near future. And of course, ever-vocal shareholders approve of the increased efficiency and speed to market brought on by advanced technology.  

The opportunities are boundless: increased productivity and efficiency; archived data that can be tracked and retrieved; cleansed data; and more valuable pharmacoeconomic indicators that enable better price justification and reveal quality-of-life factors. Of course, advanced use of information technology in clinical trial research is not without its challenges—most importantly, locating individuals who possess functional knowledge (i.e., clinical trial management, understanding of clinical data, biostatistics and data management, regulatory affairs, and pharmacovigilance) coupled with technical backgrounds. These candidates are few and far between. Alternatively, organizations can encourage information technology specialists to heighten their understanding of clinical trial research or, conversely, empower clinical trial research specialists to increase their awareness of technology. Regardless of the route taken, there are screening, training, and communication issues to consider.   

The golden candidates are those that possess both skill sets: proficiency in software programs such as Documentum, Impact, Profile, and Qumas, to name a few, with an understanding of the material, whether it be regulatory, research, or data management. However, finding these individuals can seem like an exercise in futility.   

A good alternative is hiring software developers who have specifically worked on building the software programs that pharmaceutical companies have implemented. Although these individuals do not necessarily possess life science backgrounds, they have in fact built the programs that many organizations are currently utilizing. As a result, they have a working knowledge of the clinical terminology and know what information actually needs to be captured.  

Another option is to consider information technology project managers who were hired to do business analysis for a pharmaceutical company. Through this work, they will have likely developed a business sense of clinical trials. This is particularly relevant with drug safety as third parties are often brought in to conduct an analysis. Help desk employees are also an excellent choice. Having seen it all, these individuals tend to be problem solvers, good communicators, and have already worked through software bugs.   

One such person, consultant Darren Dorman, was recruited from a help desk at a large pharmaceutical company and made the transition into a clinical environment. He has since worked as a regulatory associate and a clinical project assistant, and currently is a clinical research associate at a large pharmaceutical corporation. Dorman explains, "The learning curve is sharp because these companies are just acquiring the software and are not proficient themselves. The most valuable team members, at this stage, are those with an IT background, whether it is mainframe, LAN, Intranet, e-rooms, security, HTML, IT language, and programming. By default, they become the go-to people."      

Students and specialists developing technical skills are in hot demand. In fact, they may even want to expand their knowledge base beyond the basics by developing graphic arts, Web, and design skills. Dorman continues, "Our clinical team has recently started designing art work and advertisements to further appeal to clinical sites. Obviously, this goes beyond what most of us were trained to do but nonetheless it is becoming part of the job."         

When hiring information technologists, it is important to identify individuals who have an interest that transcends technology. Desirable characteristics include a love of learning, a natural curiosity, a desire to positively impact their work environment, and the ability to communicate complex matters to lay persons. Through interviewing and screening, organizations can look beyond previous industry experience to understand how an individual would provide value to their team.  Additionally, information technologists that have some medical background are often sought-after candidates. Former nurses, nurse practitioners, physician assistants, and pharmacists all warrant consideration.     

Communication, collaboration, & centralization

So, you have located, screened, and hired individuals. Now come the three Cs—communication, collaboration, and centralization. Communication is critical to achieving targeted business results by getting the teams talking the same language. This can be accomplished by developing a system or process that would encourage continuous exchange of thoughts and ideas to improve system functionality and process efficiency. This might be as simple as an online software "suggestion box" or as elaborate as monthly discussions on a clinical trial topic for your information technology professionals and one on technology for your clinical team. Regardless, get them talking and the collaboration will begin. Teams will be more comfortable with the material and begin to offer expertise and suggestions to improve overall efficiencies.  Hopefully at this point they will recognize that communication and collaboration alleviate confusion and lead to a better work environment. In the event that participation is minimal, try to make it worth their while! Offer incentives that are real and quantifiable: a bonus for a problem solved as a result of information technology and clinical trials working together. Publicize successes as the company's best practices. Lastly, a centralized liaison hired to bridge the gap between the technology and clinical teams will bring tremendous value and will be a worthwhile investment. This centralized resource will be able to break through the confusion and keep all parties on track. This person should be an experienced project manager and business analyst and a born communicator. They will have extensive experience driving a project and will be worth their weight in gold. This is the person to invest in, as they will ultimately lead to a successful transformation.   

There is much that an organization can do to be more strategic when staffing to fill the gap between information technology and clinical trials. Perhaps, ultimately, academic institutions will drive change through the advancement of hybrid degrees focusing on both practice areas. Companies that actively recruit from specific institutions should begin making this a priority by suggesting that colleagues and universities offer coursework that utilize software programs such as Documentum, Impact, Profile, and Qumas. Companies should make it known that the most valuable clinical candidates will be well versed in technology in addition to understanding the medical terminology and practices of conducting clinical research. They might also sponsor seminars at this level and encourage software providers to get on board by providing technology to academia.   

So, the challenge is there for employees, pharmaceutical companies, software developers, and academia. However, the good news is the successful utilization of technology will further advance the efficiency of clinical research while positively impacting the bottom line. Nevertheless, it is an exciting time to watch the progression of technology and its effects on the industry.     

 is managing director with Clinical Brokers, a member company of The Brokers Group, (609) 924-8900 ext. 207, email: 

Articles

Key screening, training, and communications techniques for putting together a strong staff.

Chris Pagotto

Articles

Building Your Clinical IT Team