Clinical Researcher—February 2026 (Volume 40, Issue 1)
PRESCRIPTIONS FOR BUSINESS
Ricky Bell
Clinical trial operations encompass a great deal of scientific precision, strict adherence to regulatory requirements, and collaborative workflows. Even with strong protocols and qualified investigators, many trials experience delays that have nothing to do with science. Instead, they originate from administrative weaknesses that quietly slow progress, inflate costs, and strain research staff.
These challenges are particularly relevant as more research sites adopt digital platforms, implement decentralized approaches, and work closely with contract research organizations (CROs), institutional review boards (IRBs), and regulatory authorities such as the U.S. Food and Drug Administration (FDA). When administrative systems fall behind, operational timelines do too.
Let’s look at the administrative weaknesses that most often impede the efficiency of clinical trials, along with practical solutions that can be put in place by organizations to enhance their performance and protect study timelines.
Fragmented Communication Across Study Teams
The smooth running of clinical trials relies heavily on the continuous interaction that takes place among the various stakeholders involved, including site staff, sponsor representatives, monitors, data managers, regulatory specialists, and patient-facing staff. When such communication takes place through slow and lengthy e-mail chains or unorganized channels, it becomes very difficult to track the critical information.
The common signs of communication fragmentation are:
- Slow responses to monitoring queries
- Inconsistent awareness of new protocol amendments
- Version control problems with study documents
- Confusion about task ownership
Fix: Improving Clinical Communication Systems
Centralization of communications through a structured platform is the most efficient solution. Research facilities are progressively incorporating clinical trial management systems (CTMSs) that integrate study calendars, protocol updates, workflows, and document repositories.
Implementing platforms that adhere to the current ICH E6(R3) guideline for Good Clinical Practice from the International Council for Harmonization not only reduces communication mistakes, it also allows simultaneous access to the same information by all team members.
Also, making staff learn to work with one communication channel instead of several parallel systems helps by reducing the number of messages exchanged, as unnecessary ones are eliminated.
Slow and Inefficient Regulatory Documentation Processes
Regulatory paperwork is still one of the most labor-intensive administrative duties in clinical trials. Documents that are necessary, like Form FDA 1572 (Statement of Investigator), delegation of authority logs, training records, and IRB submission packets, often face documentation delays because of varying workflows or manual processes.
Typical weaknesses include:
- Missing signatures
- Outdated training records
- Different versions of the same regulatory documents
- Delays in the preparation of submission-ready packets
Fix: Strengthening Regulatory Document Management
Transitioning to electronic regulatory systems that comply with 21 CFR Part 11 in the Code of Federal Regulations, the requirements of the Health Insurance Portability and Accountability Act, and ISO 27001 from the International Organization for Standardization results in a significant reduction in regulatory inefficiencies. Such systems synchronize the reviewing cycles of documents, track the different versions of a document, preserve the audit trails, and assist in submitting IRB applications in an expedited manner.
Moreover, providing standard operating procedures internally for document maintenance ensures that the most important files are always ready for inspections and that the staff is completely aware of their duties in the document’s lifecycle.
Role Confusion and Training Gaps Among Research Staff
Clinical research coordinators, investigators, and support personnel frequently manage heavy workloads. If the duties are not well defined or the people are not properly trained, then the operational consistency will be affected.
Common indicators of training and role issues include:
- Delays in reporting serious adverse events
- Lack of clarity regarding escalation paths
- Inconsistent following of protocol-required procedures
- Slow data entry and unaddressed queries
Fix: Building Up Stronger Role Competencies
Competency frameworks provided by organizations like the Association of Clinical Research Professionals and SOCRA can help sites build internal training programs that include well-organized onboarding programs, regular protocol-specific refreshers, and assessments that are done often so that employees are always aware of their functions and aligned with the site’s expectations. Clear delegation pathways, documented responsibilities, and accessible training materials create smoother workflows and reduce preventable errors that disrupt timelines.
Inefficient Screening and Enrollment Workflows
Many enrollment setbacks originate not from a lack of eligible patients, but from administrative inefficiencies within screening processes.
Administrative bottlenecks often involve:
- Delayed eligibility verification
- Incomplete pre-screening logs
- Misalignment between clinical and research staff
- Poor integration between electronic medical record (EMR) systems and recruitment tools
Fix: Enhancing the Screening and Recruitment Processes
Recruitment is sped up by the establishment of standardized workflows for pre-screening, the application of common eligibility checklists, and the linking of screening processes with the site’s EMR system.
Some sites also adopt digital outreach platforms or collaborate with community health partners to support patient identification. Timely communication between physicians and research staff remains essential for maintaining predictable enrollment curves.
Data Management Delays and Poor Query Resolution
Electronic data capture (EDC) systems facilitate the collection of clinical data, but the inefficiencies in the administration still affect the data quality processes. The major bottlenecks at the end of a study can be caused by delayed data entry and unresolved queries.
Key administrative contributors include:
- Inconsistent data entry timelines
- Limited staff training on EDC systems
- Low visibility into outstanding queries
- Weak coordination between data management and site teams
Fix: Strengthening Data Governance
Implementing same-day or next-day data entry expectations, assigning clear query management responsibilities, and using dashboards within CTMS or EDC platforms to track overdue issues foster a more proactive data environment.
Better communication between site teams and centralized data management groups also ensures that queries are addressed quickly, reducing the end-of-study backlog and supporting faster database lock.
Financial Weaknesses and Disruptions Caused by Denied Claims
One of the main challenges of clinical trials is research billing, which is a very complex administrative area. Besides the difficulty in distinguishing between standard of care and research-related costs, the precise manner of handling the payer policies and keeping up with the Centers for Medicare & Medicaid Services Clinical Trial Policy are also some of the issues that researchers encounter in billing.
When claims are denied, multiple teams must intervene. This slows down operations and disrupts budget forecasting.
Negative effects of denied claims include:
- Cash flow delays
- Unexpected expenses for the research organization
- Administrative workload for billing and research staff
- Tension between clinical departments and research administration
Fix: Implementing an Effective Denial Management Strategy
A structured denial management program identifies the causes of rejected claims, corrects documentation issues, and prevents future occurrences. Core elements include:
- Pre-authorization verification
- Accurate mapping of protocol procedures to billing grids
- Real-time reconciliation of visits and documentation
- Consistent review of payer policies
- Root-cause analysis of recurring denial patterns
Strengthening denial management processes stabilizes research budgets and reduces administrative burdens that indirectly slow trial progress.
Lengthy Contract and Budget Negotiations
Usually, delays in the startup of sites are connected with slow contract and budget reviews. Misaligned expectations between study sites, sponsors, and CROs can extend the timeline by weeks or months.
Fix: Standardizing the Contracting Process
Using established templates for Clinical Trial Agreements, confidentiality agreements, and budget exhibits speeds up the whole process. Participation of legal, finance, and compliance teams from the very beginning make sure that the contract terms meet the institutional needs.
Furthermore, the use of standardized cost schedules and providing clear justifications for the research-related expenses are other means to avoid back-and-forth exchanges.
Technology Silos That Prevent Workflow Integration
Research sites often rely on multiple independent systems, including EDC platforms, CTMS software, IRB portals, spreadsheets, and EMR platforms. When these systems do not interact, administrative workload increases.
Consequences include:
- Manual data re-entry
- Inconsistent documentation
- Delays in responding to monitors
- Increased effort for coordinators
Fix: Building an Integrated Digital Environment
Integrating clinical research systems, even to a limited extent, eliminates some of the redundancy and at the same time enhances operational transparency. Automating visit tracking, linking regulatory systems to CTMS, and aligning EMR data all contribute to smoother workflows and more efficient study management.
Monitoring Inefficiencies Caused by Administrative Readiness Issues
Monitoring delays occur when documents are incomplete, systems are disorganized, or staff are unavailable during visits. This affects oversight quality and prolongs issue resolution.
Fix: Risk-Based Approaches for Strengthening Monitoring Readiness
The risk-based monitoring method, which is in line with the ICH E6(R3) rules, directs the resources for monitoring to the places that have the most significant risk to the quality of data and the safety of patients. By focusing on critical processes and proactively preparing documents for review, sites reduce monitoring disruptions and accelerate issue resolution.
Conclusion
The robust design of clinical trials depends to a large degree upon the underpinnings of the scientific accuracy found in their protocols; however, their long-term success is very much dependent on the administrative efficiencies at play within sponsors and study sites. Enhancing communication, regulatory procedures, data management, training, financial workflows, and digital infrastructure increases the potential of all trial stakeholders to operate more efficiently and to comply with their schedules more reliably.
By fixing administrative flaws before they become serious issues, the clinical research enterprise can foster operational environments that ensure high-quality data, predictable progress, and more significant study results. As this profession continues to evolve and adopt new technologies, strong administrative foundations will remain essential for delivering efficient and reliable clinical trials.
Ricky Bell is Head of Operations at Dastify Solutions and has nine years of experience with revenue cycle management. His writing focuses on practical, results-driven solutions for modern healthcare billing.
