The clinical trial startup process has undergone considerable transformation over the past five years. The proliferation of decentralized trial models, integration of advanced technologies, and a heightened demand for expedited study timelines have all contributed to a rapidly evolving research landscape. These trends have created both opportunities and challenges for research sites, contract research organizations (CROs), and sponsors.
This blog highlights current industry insights, drawing on regulatory guidance and scientific literature, and provides practical recommendations to improve efficiency, reduce burden, and streamline study startup activities.
Increasing Trial Volume: Growth and Strain on Sites
Over the past several years, clinical research sites have reported a significant increase in trial volume. While this growth reflects the global momentum in therapeutic development, it has also introduced new operational burdens. Studies report increased strain related to the following startup tasks:
- Setup and training on sponsor technology systems
- Budget and contract negotiations
- Site and staff training
- Referral management and feasibility assessments
- Essential document collection
Conversely, activities such as patient retention, ethics committee submissions, and recruitment from internal databases are perceived as less burdensome (Pellegrino et al., 2021; EMA, 2021).
Efficiently managing a higher workload while maintaining quality requires a proactive, tailored approach to site enablement, streamlined technology integration, and collaborative sponsor-site relationships.
Sponsor-Provided Technology: Efficiency or Overload?
Technology is central to modern clinical trial conduct. Tools such as electronic data capture (EDC), interactive response technologies (IRT), and automated safety notifications are now commonplace. However, research suggests that the introduction of multiple sponsor-provided platforms-each with distinct training requirements and logins-may hinder site efficiency (Wang et al., 2020).
For example, in multicenter trials, research coordinators may manage up to six different platform logins per study, leading to confusion, training fatigue, and security concerns. Allowing sites to use single sign-on credentials or standardized platforms could reduce cognitive burden and accelerate trial startup.
EMA guidance encourages proportionate use of digital tools that do not compromise data integrity or participant safety (EMA, 2023). Likewise, the updated ICH E6(R3) GCP guideline emphasizes the importance of quality-by-design and fit-for-purpose approaches when adopting technological solutions in trials.
Feasibility Surveys: Valuable but Repetitive
Feasibility assessments remain a cornerstone of trial planning, helping sponsors determine whether a site can successfully recruit and manage the proposed study population. However, many sites report dissatisfaction with the format and frequency of feasibility questionnaires.
Common issues include:
- Redundant requests for general site information
- Repetition of previous surveys with the same sponsor
- Insufficient tailoring to protocol-specific details
Studies have highlighted that while feasibility processes have become more frequent, they are not necessarily more effective or targeted (Bergsli et al., 2021). There is a clear opportunity to standardize and digitize feasibility surveys to capture study-relevant data efficiently, reduce manual entry, and enhance sponsor-site transparency.
Contracting and Budgeting: Persistent Delays
Contract and budget negotiations remain two of the longest startup bottlenecks, especially at large academic centers. Common challenges include:
- Lengthy legal review cycles
- Misaligned budget expectations
- Delayed responses from sponsors or CROs
On average, it can take up to 8 weeks-or even longer-for sites to finalize contracts, and similar timelines apply for budget negotiations. Larger institutions may face extended negotiation cycles due to additional layers of administrative and legal oversight (Getz et al., 2020).
Efforts to address these delays include:
- Use of master service agreements
- Early budget template exchanges
- Clear documentation of indirect cost policies
- Sponsor flexibility in accepting fair market value justifications
The EMA supports streamlining study startup through improved collaboration, transparency, and consistent application of regulatory frameworks (EMA Reflection Paper, 2016).
Summary and Recommendations
The startup phase of clinical trials remains a resource-intensive endeavor. However, integrating risk-based and patient-centered practices can mitigate inefficiencies. Sponsors, CROs, and sites are encouraged to:
- Implement harmonized technology solutions and centralized credential management
- Develop feasibility processes focused on protocol-specific criteria
- Adopt standardized contract language and templates
- Collaborate early to align expectations and streamline workflows
- Promote continuous feedback mechanisms between sponsors and sites
By addressing these operational barriers, stakeholders can accelerate trial activation, enhance site satisfaction, and reduce delays in patient access to promising therapies.
Keywords: Clinical trial startup, Study feasibility, Contract negotiations, Budget planning, Sponsor technology, Site activation, Regulatory compliance, EMA, ICH E6(R3), GCP, Digital platforms, Site enablement, Research operations, CRO partnerships
References
- European Medicines Agency (EMA). (2023). Guideline on computerized systems and electronic data in clinical trials. https://www.ema.europa.eu/en/documents
- European Medicines Agency (EMA). (2016). Reflection paper on risk-based quality management in clinical trials. https://www.ema.europa.eu/en/documents
- International Council for Harmonisation (ICH). (2023). ICH E6(R3) Good Clinical Practice Draft Guideline. https://ich.org
- Pellegrino, P., et al. (2021). Risk-based monitoring and auditing in clinical trials: A review of recent practices and regulatory considerations. Therapeutic Innovation & Regulatory Science, 55(3), 497-506. https://doi.org/10.1007/s43441-020-00205-6
- Wang, J., et al. (2020). Patterns and trends in clinical trial audit findings: An analysis of sponsor audits in the United States. Contemporary Clinical Trials Communications, 19, 100597. https://doi.org/10.1016/j.conctc.2020.100597
- Bergsli, H., et al. (2021). A systematic review of feasibility assessment tools used in multicenter clinical trials. Trials, 22(1), 145. https://doi.org/10.1186/s13063-021-05126-2
- Getz, K. A., Campo, R. A., & Kaitin, K. I. (2020). Variability in study startup timelines across academic medical centers in the United States. Clinical Trials, 17(2), 177-185. https://doi.org/10.1177/1740774519895803
Empowering Your Growth with Tailored Clinical Strategies
Every clinical research project is unique and deserves a customized approach. At Lex Clinical, we guide research organizations, sponsors, and CROs through the complexities of clinical trial startup-offering strategic support in site selection, feasibility, contracting, and technology integration.
Let’s accelerate your trial startup – contact us today to get started.