Functional Service Provision (FSP) has been a successful model in clinical development activities, especially in the biometric space, for several years. Pharmaceutical companies and Clinical Research Organizations (CROs) have established many strategic relationships where a function or group of functions¹ is/are supported by one or more partners to support clinical development activities. This mass outsourcing creates opportunities for sponsors to gain access to expertise, scale, and cost efficiencies that primarily accelerate the development process. Biometric functional services, more than any other, can have a significant impact through the streamlining and standardization of data collection and management. Afterall, in clinical research, the final goal is to collect and report accurate high-quality data.

Today, in a technologically advancing world, researchers rely increasingly on eSource technologies to collect large-scale data within a shorter time span, with lesser effort. Technology that enables users to initially capture data electronically can be defined as ‘eSource’. The arrival of eSource signals a shift in conventional methods of data collection in clinical trials, offering improved data quality and process efficiency. This trend has resulted in an increased scope of data collection through multiple streams or sources, including electronic consenting (eConsent), electronic medical records (EMR), electronic health records (EHR), wearable sensors, mobile health applications (mHealth), electronic patient-reported outcomes (ePRO), and electronic clinical outcome assessments (eCOA). These technologies eliminate the traditional paper-based processes at every level of stakeholder involvement, reduce human intervention, and incorporate a shift in traditional process flows for data collection and handling.

These changes often demand significant skill improvements for teams building and managing eSource-based data collection systems, and investigator site personnel coordinating the trials. Patients and caregivers who are also the end users of these systems and tools need user-friendly interfaces and process support in order to collect accurate data. Although the proficiency of these stakeholders can vary significantly, it is important to utilize standard sets of instructions to maximize efficiency in what can be a long process, and to gain advanced and ongoing commitment of all parties involved. Bringing teams together with shared common objectives is a key strength of an FSP engagement. Individuals with experience in managing the dynamics of strategic scaled-up partnerships are invaluable in overall process flow planning, to enable seamless and successful implementation of this digital framework and down-stream processes.

Benefits for clinical trial sites:

Traditionally, technology to collect and handle data was driven by the biometrics teams; site staff did not require much orientation, other than training in the use of a single interface with EDC to facilitate data collection. Now, with the practical implementation of virtual/decentralized trials, site personnel require orientation in the handling of aspects including, but not limited to:

1. Electronic informed consent collection
2. Direct data capture (DDC) using tablets, which may sometimes be offline, for example, at satellite sites in remote areas where connectivity is an issue
3. Ensuring patients are instructed well on the use of wearables integrated with EDC
4. ePRO/eCOA usage by patients, caregivers, or support staff at sites on provisioned devices such as mobiles, tablet computers, or their own devices (referred to as the “Bring your own device” or BYOD model)
5. Ensuring data captured with EMR/EHRs flow seamlessly into integrated EDC systems
6. Connecting data platforms to validated instruments such as thermometers, glucometers, or other monitoring devices to ensure data are collected accurately

Such orientation is not easily achieved without a streamlined process in which sites are engaged with the sponsor, biometrics team, and technology service provider from the time of planning and development of the required digital infrastructure. FSP engagements can bring this to reality where processes, tools, and expectations are standardized across all data collection processes, with routine reporting between all partners.

Biometrics team as a key partner

Data quality is critical in the clinical research environment, and data handling costs do not typically constitute a significant portion of the overall trial budget. Biometrics teams, which include data management, statistics, and programming groups, which have experience of collaborating with the appropriate technology partners and proven exposure establishing key digital frameworks, are a great asset to clinical trials, and will become increasingly so in the future. Listed below are some key areas where the cross-functional expertise of a biometrics partner proves useful:

• Experience in setting up comprehensively integrated eSource solutions. The more integrated the systems, the more seamless the data flow will be, for example:
  • Solutions with multiple EDC integrated capabilities such as ePRO/eCOA, DDC, safety gateway, imaging, remote data verification etc.
• Highly collaborative data management and statistics teams where data collection is planned appropriately in advance, and in which appropriate learning from previous and ongoing studies can be implemented in future protocols and programs

Sponsors benefit by ensuring the continuity of such collaborative expertise, connecting sites, patients, and other stakeholders, in their larger clinical development portfolios. This, in turn, will bring increased efficiency, with an overall higher data quality and fewer complications. Thus, functional engagement with strong biometrics FSP partners can maximize the success of sponsors’ clinical development programs. Creating long-term strategic functional partnerships helps to streamline process standardization and reduces training needs and proficiency gaps over time.

The technology partner

The interoperability of eSource systems is key; thus, choosing the best technology partner is particularly important. The evaluation of upstream and downstream process flows at the outset of a project agreement, which can be adapted as required from time-to-time, enables an FSP framework to define clear expectations and establish dependencies. Understanding of individual indicators is important to enable a seamless process flow, starting with data collection, and ending with accurate and complete reporting. The commitment between partners in the workflow creates significant opportunity for sponsors to drive efficiencies in their clinical development goals, more easily than can be achieved with standalone partners.

Deepu Joseph is the VP & Global Head of DM for Quanticate Ltd.

References:

1. https://www.quanticate.com/functional-service-provider