Jennifer Goldsmith is vice-president of Vault at Veeva Systems.

Jennifer Goldsmith

	Managing clinical trials is an arduous process. There are many moving parts across a growing, complex ecosystem of internal and external stakeholders. Technology has alleviated some of the pain, but it has also created unintended consequences for operations teams and business leaders. Point solutions for 

, electronic trial master files (eTMFs), and clinical trials management have improved certain areas, but the clinical operations environment remains highly fragmented. 

	It’s time to move beyond a point-solution approach if a seamless, end-to-end clinical operations environment is ever going to be a reality. The challenge is that operations teams support different areas of the trial process, and naturally have their own  processes and requirements. So it makes sense that each group implements discrete solutions to address their specific needs but they also need to access a lot of the same data, documents, and information. Yet each of their disparate systems is its own island, making it difficult for groups to share content and data across workflows and business processes. 

	The simple practice of conveying the study or site information can become difficult as study IDs, site IDs, investigator names, and more are all entered into one system and then duplicated in other clinical operations systems. This creates the potential for misinformation and transcribing errors, plus forces complex integration codes that must be

 maintained. And then there are the crucial milestones that must be documented but require information stored across multiple places. These milestones may be related to study startup package completion and draw from the clinical trial management system (CTMS) and eTMF. Since each group has its own system, trying to access the same information is cumbersome. Teams often waste hours trying to get their hands on the right information amidst a sea of documentation.

	The clinical trials process is just as painful for business leaders seeking a complete, up-to-date picture of the status of a trial or portfolio of studies. No singular view exists because content and data live in different systems. Information has to be manually pieced together in spreadsheets, creating a picture that is incomplete. This makes it difficult for country leaders to make comparisons across local studies to streamline processes for study startup, ensure compliance with their portion of the TMF, or re-use documents in subsequent trials. 

	Point solutions such as eTMF and study startup software have enhanced visibility, collection, tracking, and management of content and data. They have provided measurable improvements to many aspects of the trials process, but the pieces are still not connected together to create a truly end-to-end operations environment. According to a new study by CenterWatch, in fact, sites worldwide are being inundated with a growing number of technology solutions that are difficult to use and are not compatible. On average, the typical site is working with 12 different systems to collect clinical research data.

	Something different is needed-an underlying technology platform and set of applications that are natively built and designed to manage the full clinical trial process. What’s needed now is a platform that would further streamline studies and give operations groups and business leaders everything they need at their fingertips to eliminate the manual handoffs and data collection. The task of sharing study IDs or other basics should be easy. But it’s not. Business leaders should have an accurate, up-to-date picture of clinical trials in progress, with full visibility into how their staff is managing the workflow, data, and business processes. And they don’t … at least, not yet. 

 is Senior Vice President, Veeva Vault, Veeva Systems 

Articles

The need to move beyond a point-solutions approach to one built around applications designed to manage the end-to-end clinical trial process is crucial.

It’s Time to Transform Clinical Trial Operations

	Launching a new clinical study is an exciting stage of product development. There is tremendous hope that a new drug will cure illness or bring relief to patients. Inspired, the team jumps in with a sense of urgency â but as documents and tasks pile up, bottlenecks emerge that delay getting actual research started, threatening the team’s ability to meet key study milestones for product registration. 

	Study startup has many moving parts with numerous activities happening among multiple parties in parallel. The protocol is written; investigator sites are evaluated and selected; clinical trial applications are prepared; ethics committee submissions are developed; investigators and clinical trial team members are trained; investigational product is formulated and packaged â and the list goes on. To further complicate matters, different regulatory requirements must be met across the globe and various disciplines and stakeholders (i.e., researchers, physicians, lawyers, regulators, ethicists, investigators, scientists, and monitors) are involved in the process. As is so often the case today, many team members are added to the mix in support of the study â CROs, labs, technology vendors, and others. 

	The study “Benchmarking the Study Initiation Process” published in 

Therapeutic Innovation & Regulatory Science

 collaborated with 11 pharmaceutical and biotechnology companies to examine 105 global clinical trials and confirms this inefficiency. “Due to the volume of activities required at study startup,” the researchers reported, “many companies have recognized this phase as a bottleneck and are looking specifically at the study initiation process as a key improvement area.”

	The life sciences industry continues to rely heavily on paper-based processes and low-tech systems to share and collaborate on critical study startup materials. Documents or disks are mailed or couriered across the globe, and spreadsheets are used to track and manage progress. When a typical Phase III study requires hundreds or even thousands of patients to confirm efficacy, many international investigator sites are needed, each with local regulatory and institutional site initiation requirements.  With this volume and complexity, it’s not surprising that clinical research teams struggle to make progress using Excel spreadsheets to manage their work.

	In addition to being inherently slow, these manual processes prevent all stakeholders or process participants from overseeing progress or tracking status. The problem is compounded with international teams as regional groups often maintain their own records, which may not correspond with records at headquarters. Almost no one on the study team has real-time visibility, forcing organizations to be reactive â looking back at problems instead of taking preventative action. This situation creates many opportunities for error, exposes companies to risk, and plays a direct role in study setbacks. 

	One flaw in current technology solutions for study startup is that they provide a detailed picture of either the documents or the operational data, but not both at the same time. While some solutions help because they enable the team to see and access all needed documents in one place, they don’t connect the documents with operational information the team needs to efficiently initiate the study. Existing systems often do not help manage the work processes involved, either. Automating simple workflows, such as routing documents for approval or quality control, can have a large impact on time to first patient and time to first visit.

	There are a handful of specific study startup applications on the market today, but spreadsheets and clinical trials management systems (CTMS) are the most commonly leveraged tools across the industry. Spreadsheets don’t provide global team visibility, create version control issues, and require manual effort for entry, updating, and checking. The CTMS offers functionality for planning and tracking, but this type of system can be complex and inflexible to manage the local requirements in a global study startup process. The CTMS provides limited ability to manage or process documents.

	Some specific study startup solutions endeavor to combine operational data from different systems and provide a very clear visualization of the startup process in one place so everyone can see where progress is lagging and where they need to take corrective action. If the data is updated in real time, this can help, but delays in integrating data can cause inefficiency for study teams. And, although the data are visible, these systems don’t link the data to the documents the team needs in order to take action immediately.  

	“Many sponsors and CROs have traditionally used unsophisticated, disparate, and incompatible proprietary and customized approaches and eClinical solutions to manage study startup and initiation activities,” says Ken Getz, associate professor at CSDD Tufts University School of Medicine. “This has contributed to the historically high level of inefficiency and inconsistency that we’ve observed in investigative site engagement and activation.”

	Through the evolution of study startup solutions â from paper and Microsoft Excel tracking sheets to dedicated software applications that capture and leverage metadata as users create, review, and distribute content within the system â it is now possible to bring documents and data together. As a result, all team members across geographies can see what documents or data that is missing from the TMF without toggling to different sources or emailing various people. It’s all in one place, which also enables the team to then immediately take action. Sponsors, CROs, and local study team members can update documents and operational data at that central source and manage workflows and work processes, ensuring version control, enabling planning, and speeding the activities of study startup. 

	Often, because of the complexity in the clinical study process, team members don’t have the information they need to prioritize their work. They need to know which activities are most vital for keeping study start up on the path, and which occurrences will delay the projected study start date. Integrated solutions improve communication among team members spread across the enterprise as well as between sponsors and CROs, which increases visibility of all tasks, eliminates redundancies, and enables the team to move forward at a faster pace. 

	Awareness of the problems with study startup is very high and a number of efforts to solve them are underway. Many organizations have created new positions solely with the objective to oversee and improve the startup process. Accelerating the time to first patient is seen as key to driving study efficiencies. 

	Additionally, many industry groups are also focusing on simplifying and speeding the time it takes to begin research. TransCelerate BioPharma Inc., a coalition of large pharmaceutical companies, has launched a program focused on speeding study startup timelines by developing standard criteria for recognition of good clinical practice (GCP) training and site qualification.

 The TMF Reference Model, maintained by an industry group of almost 200 life sciences companies, provides standard structure and taxonomy for maintaining a GCP-compliant trial master file (TMF), which includes many of the documents collected during study startup. And, the Metrics Champions Consortium has outlined a number of activities related to site activation as part of their Clinical Trial Performance Metrics Set.

	These types of industry-wide collaboration are essential and pave the way for meaningful transformation of the study startup process. Consistent processes and industry-wide standards help sites, CROs, sponsors, and regulatory authorities work together more effectively. The application of new technologies represents the other side of the solution. Linking documents and data for a complete view of the startup process, and then being able to act on that information provides a new opportunity to solve the study startup challenge, once and for all.

		“Benchmarking the Study Initiation Process,” by Lamberti, Brothers, Manak, and Getz, Therapeutic Innovation & Regulatory Science (2013) 47: 101. For more: 

		FDA, "Frequently Asked Questions-Statement of Investigator (Form FDA 1572)," (2010). For more: 

http://www.fda.gov/downloads/regulatoryinformation/guidances/ucm214282.pdf

		"TransCelerate Initiatives," by TransCelerate BioPharma Inc., (2013). For more: 

http://transceleratebiopharmainc.com/?4a17eb50

		"J&J, Lilly, Merck Plan Clinical Trial Site Database," by D. Beasley, Reuters, (2012). For more: 

http://www.reuters.com/article/2012/11/15/us-pharmaceuticals-trials-idUSBRE8AE0XS20121115

	Jennifer Goldsmith is the Vice Presisent of Veeva Vault and can be reached at jennifer.goldsmith@veeva.com

While launching a new clinical study is an exciting stage of product development for trial personnel, road blocks can emerge. A new approach is needed to cope with the volume of activates required for the study product registration.

Jennifer Goldsmith

Articles

It’s Time to Transform Clinical Trial Operations

A New Approach to an Old Problem – Speeding Study Startup