Clinical Research Industry

Professional Clinical Research IT Services

Implementation of IRB, CTMS, eTMF, eCRF, EDC and more

Clinical Research and Information Technology

The clinical research industry deals with determining the safety and effectiveness of medications, diagnostic products, and patient treatment processes. Due to globalization and the regulatory reforms across the world, it is constantly evolving. The implementation of innovative clinical research solutions and technologies in recent years aims to facilitate all aspects of this industry. The IT solutions prove to be not only time- and cost-effective, but also highly beneficial in terms of streamlining researchers job and increasing patient participation in clinical trials. Some of the innovations that reshape the industry include wearable technologies, patient monitoring systems, tools that ease patient recruitment, and many others. We, as a custom software development company with 11+ years of experience, also focus on developing tailored solutions for managing clinical trials.

IT challenges and solutions for the Clinical Research Industry

Vendors, CROs, clinical professionals, organizations, and departments face numerous challenges on a daily basis. Most commonly, these challenges refer to trial costs, patient recruitment, and retention, acquisition or collection of clinical trial data, regulatory requirements, adoption of innovative technology, inadequate research training, keeping track of the paperwork generated throughout the patient enrolment process, etc. The IT industry offers a variety of time- and cost-effective solutions, which can facilitate the overall clinical trial conduction process. For example, standardized electronic CRFs are just one of the solutions, which can reduce trial costs, and which can help clinical investigators be more efficient.

Ensuring high quality and accuracy of clinical trials is of great importance for the safety of clinical trial subjects and for preserving the quality of the generated data. Clinical trial systems facilitate all processes during the conduction of clinical trials, including:

  • gathering, processing, storing of data
  • electronic authorization
  • adherence to the regulatory and governance requirements
  • post-approval monitoring and reporting
  • tracking the whole clinical research trials application review process

Proper documentation and data storage plays an important role in the overall clinical research conduction process. The new technological advances like EHR (electronic health records), which ensure a paperless environment for the clinical research is highly beneficial for the safety of patients, reduction of medical errors, and improved patient outcomes.

Our experience

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Over the last decade, BGO Software has provided end-to-end custom software and SaaS solutions for the clinical research industry. Our software solutions ensure a high level of security and efficiency for our clients’ projects. They result in a time- and cost-effectiveness and ensure stricter access control. We develop regulatory compliance projects while meeting all customers’ requirements.

BGO Software develops software for the UK NHS and is an official software supplier for the Health Research Authority HRA. Our solutions are also integrated with systems operated by the Medicines and Healthcare Products Regulatory Agency MHRA and the National Institute for Health Research NIHR. We have also developed a comprehensive risk-based monitoring system for a Top 3 Global CRO.  Оur processes ensure ongoing alignment with existing ISO standards (ISO 9001 and ISO 27001).

We have recently developed our own product – an advanced clinical trial management system called CliniCubes. The CTMS is fully customizable and is able to fit into any enterprise culture, without requiring major changes.

Software solutions for the clinical research industry

By implementing the latest technologies and trends, BGO Software delivers cost-effective and efficient projects. Here are some of the clinical research solutions that we offer:

Risk-based monitoring solutions

This sophisticated solution supports the identification of the sites within the organization’s network with a higher risk factor for poor performance. It can help clinical research organizations save billions of dollars.

Clinical trial management systems (CTMS)

We have developed a web-based clinical trial management system, which is 100% modifiable to your organization’s needs while complying with regulatory requirements. Additionally, Clinicubes CTMS can be quickly adapted to facilitate your firm’s procedures and workflows and it serves as the perfect hybrid between ready-made (“off the shelf software“) and a custom software solution.

Research Ethics Review Systems (IRB)

The ethical review process system for Health & Social Care Research that we have developed – HARP, manages the process of booking applications onto research ethics committees. The system is compliant with the requirements of the UK RECs review and international institutional review boards (IRB).

Electronic trial master file (eTMF)

This type of content management system designed for the pharmaceutical industry facilitates the process of organizing and storing regulated clinical trial content. This digital content consists of documents and images for pharma clinical trials, which may be required for compliance with government regulatory agencies. The eTMF ensures that your organization is always inspection-ready. It also ensures reduced costs, expedites clinical trial approval processes, minimizes business and data security risks, while still being compliant with FDA regulatory policies.

Electronic case report form (eCRF)

An electronic case report form is a tool used to facilitate the collection of consistent and valid data from each participating patient in a clinical trial. It accelerates this process, as all patient data (including data from patient questionnaires, and about adverse events) are directly entered into the database. The numerous advantages of eCRF include improved data security and quality, cost-effectiveness, environmental friendliness, and faster but stricter data accessibility and easy analysis.

Electronic data capture (EDC) systems

EDC systems are designed to simplify the collection of clinical data in electronic format and are generally applicable to human clinical trials. Used commonly by CROs and pharma companies, these systems aim at replacing the traditional paper-based data collection methodology by ensuring streamlined and accelerated data collection and drugs and medical devices releases to the market. Except for reducing paper management time, EDC systems are also highly beneficial, as they minimize the risks of illegible data issues.

 

CliniCubes CTMS

CliniCubes CTMS is a specialized Software as a Service solution, which is used to streamline the process of clinical trial management. The system enhances the sharing of information, guarantees cost-effectiveness and ensures timely delivery of results. This CTMS is designed to simplify any process behind clinical trials. A significant benefit is a fact that the system can be entirely customized to fit the requirements and needs of any enterprise.

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