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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

 

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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

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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

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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

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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

iRAW


intelligent raw data archiving watcher
RAW Data, GxP Lab, Controls, SEND, loT

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iPQM


intelligent pharma quality management
QMS, qDMS, CAPA, Image QC, Issue Management

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BRAIN+
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iTMF


intelligent trial master file
DIA eTMF, CRO Migration, Longterm Archiving

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COMPLY+
MIGRATE+

As well as all other Add-ons ...

iRCS


intelligent regulated content services
rDMS, RIM robot, IDMP/SPOR, promo mats

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As well as all other Add-ons ...

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