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Tag: Clinical Trial Management

  • How Clinical Trial Software is used to Improve Clinical Trials?

    How Clinical Trial Software is used to Improve Clinical Trials?

    Clinical trial software streamlines clinical studies from start to completion. Some examples include protocol management, CRF design, metadata management, and the collection, analysis, and reporting of compliance clinical research data to regulatory authorities.The goal is to deliver high-quality clinical goods to the market as quickly as possible.

    Spreadsheets have traditionally been used to document and manage all elements of clinical studies. That implies a significant chance of mistakes, a lack of crucial data, and bottlenecks in the process. As a result, efficiency, compliance, and patient care have all been jeopardized.

    To keep ahead of rivals, the industry now recognizes that technical cloud-based clinical trial software solutions are critical for faster, more effective clinical trials. In addition, the FDA has advocated for the adoption of cloud-based technology to expedite the clinical trial process.

    Clinical trial software types

    Clinical trial software includes a wide range of software for various phases of the clinical trial process. Among them are the following:

    • CTMS (Clinical Trial Management System) 
    • EDC (Electronic Data Capture System) 
    • Integrated clinical study automation software

    What exactly is a CTMS?

    A clinical trial management system (CTMS) is a cloud-based software platform used to manage clinical studies from start to finish. They are employed in the planning, tracking, and analysis of clinical studies. They assist businesses in improving the quality of their clinical goods, reducing the time it takes to bring a product to market, and ensuring compliance with industry standards and laws. And to locate and manage patients who are willing to participate in clinical studies and track their participation in clinical trials and handle funds.

    CTMS are frequently used with other clinical trial software specializing in a particular area, such as EDCs and integrated clinical study automation software.

    What exactly is an EDC system?

    It is a computerized system that allows users to collect patient data during clinical studies. They usually have a user interface that allows users to enter data into electronic forms. Validation is used to ensure that documents have been filled out correctly. In addition, a reporting tool is provided to allow users to evaluate the acquired data.

    EDCs have been around since the 1990s and are constantly developing. You can target specific patient characteristics or research stages with modern EDCs. Cloud data storage, role-based permissions, CRF designers, clinical data analytics, interactive dashboards, and electronic health record integration are some examples of contemporary features.

    What exactly does integrated clinical trial automation software imply?

    Clinical study automation software is a cloud-based integrated program that focuses on specific aspects of a clinical trial. CRF designers, metadata management, standards governance, data storage, statistical computation, and submission to regulatory agencies are examples of these sorts of systems.

    Where does the industry stand currently in terms of clinical trial software?

    The pharmaceutical sector has been hesitant to experiment with novel techniques and developing IT technologies. Its exclusive concentration has been on bringing clinical medicines to market.

    What are you waiting for? Enroll Now for our Clinical Trial Management certificate program. It is designed in such a way that it will meet the industrial requirements.

  • How to Improve Clinical Trial Recruitment?

    How to Improve Clinical Trial Recruitment?

    Clinical trials are necessary for medical research. Producing new medicines to the market depends on the strength of research organizations and drug companies to test and verify their work vigorously through their Clinical Trials, but finding people willing to participate is notoriously tricky.

    Researchers rely on a constant stream of volunteers to test and validate their outcomes. Recruiting patients for clinical trials is difficult. The latest survey from Clinical Trials Transformation Initiative (CTTI) recorded that protocol-related and clinician-related effects are essential obstacles to recruitment; yet, patient-related blocks also majorly affect the success or failure of clinical enrolment. Limitations include patient perceptions and information about clinical trials, lack of awareness about possibilities to participate in studies, concerns about placebos, travel time, and trial-related expenses.

    Streamline patient testing with the point of care testing devices

    The accumulation of too much data or additional trial methods can lead to more persistent study visits and anticipate streamlining of study design. When addressing the study protocol, firms should recognize the potential influence of selecting medical equipment on patient enrolment and retention.

    Use social media and mobile platforms.

    How patients discover clinical trials has transformed over the years. Before, patients received about practices via media, mail, and their HCPs. Thanks to social media and smartphones, communication is much more direct today. Social media platforms like Twitter and Facebook have made it comparatively easy to recruit patients for clinical trials. Clinical trial sponsors and CROs have nudged up to the power of social media in reaching ‘e-patients.’

    Address patient concerns

    Misunderstandings about clinical trials are amongst the fundamental reasons patients miss chances to be handled within research settings. By building an effort to reach out to patients with available information, companies can dismiss these fears. 

    In producing and managing the trial, study managers should also ensure patients that they will be treated with respect and maintenance at each stage of the study.

    Make the process patient-centric

    The patient recruitment method should depend on individual patients and not diseases. The study design should include the patients’ decisions to ensure the clinical trial has meaningful endpoints. If a clinical trial doesn’t meet real patient requirements, it makes recruitment even more challenging. To make the procurement process patient-centered:

    • Getting feedback from patients about the study design
    • Engaging patients, their peers, and the community as volunteers in the trials
    • Giving input about clinical results
    • Producing research programs
    Improve patient screening methods

    Once patients have been recognized, an efficient screening process needs little travel and is minimally invasive. Thanks to technologies like random sampling, these methods are now possible. They enable applicants to submit their samples from wherever they are without visiting the research facility. 

    Remote reporting

    In recent years, the number and frequency of data points being collected during studies have increased massively. It implies members now coping with complex health requirements are being asked to travel further and attend more.

    But in an environment of instant messaging, wearables, and video calls, there is little demand. Regulatory bodies have accepted this and no longer need 100% on-site monitoring, which can significantly affect a sponsor’s ability to recruit and retain sufficient people to test their product adequately.

    One size doesn’t fit all.

    While companies can use several practical steps to successful patient recruitment limitations, one size does not fit all. Study managers should design an action plan at the start of each trial and ensure they partner with vendors excellently placed to help them achieve their specific goals for the study. The right combination of strategies will provide study managers to tailor their approach, so it works for different patient groups and physicians to enhance patient enrolment and long-term retention.

    Start your path to a career in Clinical Trial Management.The curriculum is focused on enhancing your ability at every stage of the clinical research process.

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