clinical

CLINICAL

Essential documents and the conduct of a clinical trial

A successful close-out of a trial can only be done when the monitor has reviewed both investigator/institution and sponsor files and confirmed that all necessary documents are in the appropriate files. In order to be quick in the study close-out, these Trial Master Files should be established at the very beginning of each trial, both at the investigator/institution’s site and at the sponsor's office. Today, with an biomedion eTMF system, this critical task becomes easy to track and report. With that in mind, its priority to keep up with patient recruitment over distance, the adoption of technology, and regulations and eventually saving costs at the same time. Beside the common factors, COVID-19 draws a new class of challenges to clinical trials in 2020 (read more in Nature, as of 18 May 2020).

Typical challenges for running trials in 2020 are:

Increasing complexity of trials
Changing regulations, also COVID-19 related Interims regulations
Cost of trials at all-time high
Patient recruitment and retention
Hiring and training of trial staff
Acceptance gain caused by technology
CROs, partnerships and oversight
New drugs, new ways of running trials

Trial Startup

Study startup remains in focus, because it has still such an impact on clinical trials — and can be considered as part of the critical path to the success of a medicinal product. Any problem with the study startup, more than any other aspect of a clinical trial, draw a substantial risk to increase timelines and budgets.

HIGHLIGHTS

Collaborative Authoring
Trial Design
Patient recruitment, screening, and enrollment
Workflow management of the entire protocol's life cycle

Trial Conduct

The highest priority in terms of compliance while conducting clinical trials is protection of human subjects and patients. Compliance issues like protocol deviations or violations in the clinical trials remain an issue. Current findings in regard to trials conduct show the need for tools to endure quality and data integrity not only to fulfill the Code of Federal Regulations (CFR).

HIGHLIGHTS

Study conduct and project management
Monitoring visit reports
Close-out and analytics
Validated Reports, Ad-hoc reports

Trial Site Management

Clinical trial sponsors face many challenges in clinical trials – including how to mitigate risks that could cause delays and increase trial costs. What are some of the challenges that sponsors and CROs currently face when managing trial performance? How can sponsors and CROs use technology to overcome these challenges?

HIGHLIGHTS

Vendor Management
Investigator Management
Site Identification
Trial Planning and Startup
Site preparation

eTMF and Archiving

To comply with regulatory government policies, clinical research organizations need to keep records of essential documents that are stored in the trial master files (TMF). The TMF allows independent auditors and regulatory authorities to monitor and evaluate the quality of the data produced by a clinical study.

HIGHLIGHTS

eTMF integration
Archiving
Actual document statuses and updates,
Fully integrated with CTMS workflow events and triggers