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International Clinical Trials

Head Start

Clinical trial site activation is a complex endeavour, requiring adherence to legislation and Good Clinical Practice (GCP). The process has many complicated layers of procedure and documentation, including numerous activities such as protocol design, country feasibility and standard of care, site identification, budgeting, contracting, and essential site regulatory document collection. It is still largely managed manually, with an overwhelming volume of spreadsheets and electronic communications.

Added to this start-up process is the complexity of addressing the requirements of multiple stakeholders, including an institutional review board, CROs with various areas of expertise, internal groups and different regulations and requirements in every country. All stakeholders must be coordinated, and the multitude of activities must be completed before sites can start enrolling patients.

Unfortunately, the inefficiencies and delays inherent to the process often create significant investigator dissatisfaction, even before a clinical trial begins. In a 2015 global survey of investigator sites, 46% of respondents said the complexity and time commitment required to complete just two facets of start-up – clinical trial agreements (CTAs) and essential regulatory document collection – is extremely burdensome and a major obstacle to trial participation (1).

From a sponsor perspective, inefficient study start-up adds needless and costly delays to enrolment, yet sponsors are slow to adopt new technology that can streamline the site activation process. Site activation technology – cloud-based or other – has the potential to improve start-up cycle times by a minimum of 20%, and vastly reduce the perceived level of burden by investigators. There are three models that employ technology to improve the efficiency of site activation for sponsors, CROs and investigator sites, which will be discussed later.

How Site Activation Systems Work


Site activation technology systems are a welcome disruption to the start-up process. System features can include multi-tier quality control review for essential site regulatory documents, standard operating procedures, training programmes, periodic audits, and managerial governance to ensure compliance with ICH GCP regulations.

Workflow optimisation, notifications that advise site personnel of new actions, and transparent reporting provide proactive project management and expedite activity. Additionally, if single sign-on is available, this can further streamline administrative burdens by enabling stakeholders to log into the technology platform, in order to access multiple studies and manage and inform on all active trials across their portfolio. Dashboards allow sponsors and CROs to track, view and report on multiple studies, highlighting common areas of inefficiency that need to be addressed beyond a study-specific level.

Looking at two areas cited by investigators as the most strenuous, administrative tasks of site start-up – CTA agreements and essential regulatory document collection – we can see how site activation technology can improve the process.

Site contracting can become even more efficient when negotiators can easily leverage historical contract terms previously used with the investigator site. A technology vendor can create, negotiate and manage CTAs from draft through execution, while the sponsor/CRO remains in control of the entire contract lifecycle as all activities are visible to them. The CTA budget negotiation can be done simultaneously in a separate workflow, which can route budgets to the relevant budget site contact. Cycle times are, therefore, improved because of the transparency of the system for investigators, sponsors and CROs – with each party knowing exactly which stage each document has reached, and who is responsible for the next action.

For essential regulatory documents, a workflow engine within a site activation system can simplify document exchange. Documents collected during start-up need to be tracked over time and maintained for the lifetime of the study. An automated system provides a straightforward way to recognise when documents are approaching expiration, and automatically advise sites.

Optimising the Technology

Every trial is different. By using technology, rather than a manual process, sponsors and CROs can create a start-up strategy that best suits their business and company culture. There are three models for consideration to speed site activation:

Business Process Outsourcing
The business process outsourcing (BPO) model works well for small- or medium-sized sponsors, who need a flexible resource pool of site activation experts who are able to adjust to changes in their development pipeline, so they can focus resources on core operations of science and sites.

With this model, the sponsor completely outsources site activation to a speciality company that is a subject matter expert in that clinical procedure, and offers technologyenabled services that automate many steps in the site activation process. The BPO model provides resourcing efficiency and flexibility for the sponsor that does not have the infrastructure and resources to manage their studies.

The service provider oversees the process with their own team and technology. Fees are generally charged on a per site basis. The service provider should be a specialist in a functional area that can also offer support in countries or regions with which the sponsor is not familiar. The advantage of this model is that sponsors can gain transparency into their studies, including real time access to dashboarding and metrics, but all the work is completed by the vendor partner. The disadvantage of this model can be if the BPO provider’s software is less customised than a software as a service (SaaS) model, because it is tailored to many customers’ needs.

Internal Use SaaS Technology
The SaaS model works well for sponsors with a team of highly skilled individuals, who are encumbered with a manual site activation process that is largely driven by email and numerous Excel-based trackers. The sponsor or CRO can leverage site activation technology, but use their own skilled workers. This model supports collaboration between sponsors, CROs and sites by providing a centralised system for multiple stakeholders, and transparency into the real time status for all relevant activities. Perhaps the most appealing aspect is the flexibility, customisation and choice it offers to stakeholders.

Developed by an expert solution provider, and accessed through the cloud, this technology is typically priced as a subscription. There is no capital outlay for development of the software. It can be up and running quickly, because the solution is ready to go out-of-the-box with configuration to align with internal processes. In addition, it can significantly reduce the amount of time, resources and administration required to engage and activate investigator sites.

An example of a typical SaaS user might be a large pharma company that has a system in place offering legal and negotiation training for their study start-up group. They may have expert contract negotiators, but their process is manual. It can be quite expensive to develop a new system internally. The SaaS model would provide the latest customisable technology to update their tool set, so they can use their experienced and trained internal team to complete the contract negotiations with the benefit of a technology hub.

Hybrid Model
This model offers in-sourced technology, with subject matter experts available for project management, best practice recommendations and overflow support. It can be seen as offering the best of both worlds, because it provides a common, easy to use software hub allowing for transparency and collaboration, but the sponsor/CRO keeps control of the process.

Some sponsors and CROs choose this hybrid approach – which incorporates aspects of models 1 and 2 – to take advantage of the expertise of the technology partner, and to stay more involved with the sites and investigators, or to support company guidelines that require more oversight. An example of this model might be a larger sponsor that has established partnerships – one for contracting, one for regulatory documents, and various CROs or company offices with country access and expertise.

Pricing varies, but usually includes a subscription fee for use of the technology, along with a project management fee to cover the resources provided for by the solution provider.

Model Evaluation

To determine which site activation model is more suited to your organisation, consider the following questions and complete the survey (see full PDF) to identify your priorities.
  • Is the technology simple and intuitive, so non-technical people can adapt to the system quickly?
The system should allow for different levels of users, including ‘super users’; however, the set-up and management of the system should not require an IT background. This is very important for the SaaS model in particular, as you do not want to depend on your vendor to make minor changes to your workflow for every study. The point of SaaS is to remain independent. If you prefer to maintain a good relationship with your vendors, be involved with the roadmap and ongoing enhancements made to the technology, and receive support but maintain the independence to manage the day-to-day operation, this model could work well for you.
  • Does the system integrate with electronic trial master file (eTMF) and other clinical systems?
The system should help create efficiencies and reduce administrative burdens for sponsors and CROs, so it is imperative that it integrates easily with other clinical systems. If it is not possible to create an automated integration, a feature that exports all finalised documents by site in a file structure that matches your eTMF file structure requirements is still a very large leap forward for the majority of sponsors.
  • Can workflow be customised to accommodate various roles and business processes for different studies?
This question is critical when evaluating SaaS solutions, since the point of getting new technology is to reduce the site, sponsor and CRO administrative burden. For example, sites have many different roles – such as a legal or a financial contact – who receive the relevant documents for review. Various sponsor roles include legal or regulatory contacts. Having specific roles for both sites and sponsors streamlines the workflow, and substantially reduces the amount of erroneous communication. CTA negotiations/ redline changes are sent to the appropriate person in the legal department, while the informed consent form negotiations are sent to the appropriate person on the regulatory clinical team.

Once you have answered these questions, take the survey to identify the best model for your company culture and resources (seefull PDF).

Enhanced Operations

Emerging technologies are putting an end to the days of relying on email, manual spreadsheets, and hundreds of work hours to manage site activation.

With new technologies, sponsors and CROs can activate sites quickly so they can start enrolling patients. Making investigators’ and sites’ lives easier before the trial begins can have a significant positive effect by decreasing the rate of investigator and site turnover. This benefits all stakeholders.

Let us speed up the adoption of this important technology to find the right sites, get them activated, and set them up for success as quickly as possible so pharma can conduct many more trials that bring new medicines to patients.

Reference

1. Cascade E and Sears C, Access and attitude to clinical trial technology: The global investigator perspective, September 2015

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Melissa Easy is the founder of DrugDev and current President of the SiteStart Division. For years, the company has helped sponsors and CROs reduce the time of site activation by 20-50%, with expert outsourcing services for CTA negotiation, budget development and essential regulatory document collection. Recently, the business made its technology available as a SaaS solution, to support internal study teams as they improve global start-up processes.
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