The shift by the life science industry to the development of more novel medicines for rare diseases is further complicating the structure of clinical trials. In 2015, nearly half (47%) of FDA-approved drugs were for rare diseases, including therapies for cancer, cystic fibrosis, difficult-to-treat high cholesterol, and several enzyme deficiency disorders. Currently, more than 560 medicines are in development for rare diseases.¹  
 
Associated with these new niche medicines are more scientific unknowns, few specialized clinicians to serve as investigators, smaller patient populations to serve in trials and greater numbers of international trial sites. At the same time, life science companies are facing more stringent regulatory requirements, more assessments and higher volumes of data to manage, analyze and report. PhRMA notes that during the last decade, clinical trial designs and procedures have become increasingly complex, demanding more staff time and effort.²
 
To remain focused on core competencies while addressing new clinical trial requirements and complexities, life sciences companies are relying on contracted resources to play a larger role in supporting the clinical trial process. Both large and small biotechs alike are making a move to extend their alliances with Clinical Research Organizations (CROs) to manage processes, identify risks, and accelerate time to market.
 
Moving from transaction problem-solver to long-term strategic partner requires CROs to implement new project management business models. It also requires an evolution in the role of the project manager.
 
Evolution of the CRO Project Manager
Traditionally, project managers followed a defined scope of work to complete clinical activities on time and within budget. They worked according to simple management practices, adhering to the service triangle of time, cost, and quality.³ Now, CROs have greater expectations for PMs to proactively manage and control processes and offer innovative solutions to risk – all with an eye on improving ROI. Many are tasked with managing even larger groups of stakeholders composed of internal and external team members as well as customers. 
 
The generation of large subsets of data from various sources requires advanced analytic skills to pinpoint outliers and report results to sponsors. Rather than be reactive to problems, PMs must work proactively to mitigate risk before it causes delays, added costs or other problems.   As ‘CEO’ of the project, they must govern the entire project cycle to ensure milestones are met in alignment with sponsor objectives while finding ways to decrease cost and speed time to market.³ 
 
In talking with Leslie Jones, executive director of clinical operations at ResearchPoint Global, a full-service contract research organization for small- to mid-sized pharmaceutical and medical device companies, she noted that the “buck stops at the PM.”  From her experience, she finds there is a greater expectation that PMs should see everything that is happening in the trial so they can manage risk. While not a new idea, expectations are higher for CRO project managers to identify issues early, offer solutions, and effectively implement change.
 
Enterprise Project Collaboration Software Can Make a Difference 
While PM responsibilities have changed, technology and training haven’t kept pace. Many project leaders are not receiving the education or tools to succeed in this new environment. Unfortunately, many PMs are stuck with yesterday’s technology such as email, spreadsheets and basic file share systems that only offer generic functionality and that don’t integrate among them or provide the features to support automated workflows, concurrent document reviews, and advanced data management/analysis. Also, PMs face the dilemma of different stakeholders working with legacy and incompatible systems that don’t support collaboration.   
 
What’s needed is a platform that seamlessly integrates all team players, providing for real-time visibility into data and work tasks so both PMs and their sponsors can retain oversight of operations. It must eliminate redundant data re-entry and provide a single source of truth that removes the worry of which file is the latest version and who completed the task.  
 
Cloud-based enterprise project collaboration (EPC) software addresses all these concerns by centrally connecting all project stakeholders onto a single platform.  The results are streamlined communication, coordination, and collaboration. With pertinent information centralized onto one source, PMs can have the most current data on any given task at their fingertips to make informed decisions and work proactively with teams to address different milestones. As sponsors often want to be kept in the loop, the EPC software provides two-way transparency, so that the CRO can see what the PM sees at any given time.
 
Chris Meyer, senior director of program management at biopharmaceutical company Axial Biotherapeutics, implemented EPC software at a previous organization and is planning to do the same at Axial.  He noted that by combining existing tools along with innovative new features offered by EPC software, PMs could work much more efficiently and strategically.  “With greater transparency into processes from end to end, the PM can proactively monitor team progress and identify potential risks that can hinder progress, he explained to me.  “Overall, EPC supports a shift in the mentality of how to manage clinical trials.”
 
Demands on CRO PMs will continue to grow as clinical trials get more complicated. Only with the right technology can PMs be expected to take the strategic lead to accomplish more while managing larger workloads to provide real value to life sciences companies.

Sources:
1 PhRMA, (2016) Medicines in Development for Rare Diseases: Report on Orphan Drugs in the Pipeline.For more: http://phrma-docs.phrma.org/sites/default/files/pdf/medicines-in-development-report-rare-diseases.pdf 
 
1 PhRMA, (March 3, 2011) Clinical Trials – So Necessary But More Complex Than Ever.  Retrieved from: http://catalyst.phrma.org/clinical-trials-so-necessary-but-more-complex-than-ever  
 
3 Hack, Volker, Sackner, Denise. (June 1, 2017) The Changing Role of the CRO:  Impact on Project Management.  Retrieved from: http://www.appliedclinicaltrialsonline.com/changing-role-cro-impact-project-management?pageID=1