Clinical Trial Management Software: A New Way to Streamline the Treatment Development Process
Published December 23, 2019
Clinical trials are performed in a patient population to evaluate interventions. For example, they’re often used to investigate if new treatments are more effective and/or less harmful than the standard of care. They can also test the effectiveness of diagnostic products in their ability to find disease early, before symptoms occur.
What Goes Into a Clinical Trial?
Formal clinical trials are huge administrative undertakings. They involve a highly regulated process consisting of four trial phases: three of these phases are performed to discover the effectiveness and safety of the innovation, while the last phase is a population-based monitoring process after approval by regulatory bodies.
Phase I: A small group experiment using healthy participants to judge the safety, side effects and dosing of the treatment.
Phase II: An effectiveness experiment using a larger group of participants with the disease or condition of interest. This phase is designed to obtain preliminary data on whether the treatment works and can last several years.
Phase III: A large study to further investigate treatment safety and effectiveness, this time studying in different populations and using different doses. If Phase III trial results are positive, then the treatment is approved by regulatory bodies to enter the market.
Phase IV: Conducted while the treatment is in use, Phase IV involves monitoring treatment effectiveness and safety in large, diverse populations. This ongoing trial is crucial because some side effects do not appear until more people have undergone the treatment over a longer period of time.
At every step of the process, researchers are required to ensure the research follows regulatory guidelines. Each phase of the trial requires managing several tasks in planning, implementation and reporting, which must be performed to the highest standard.
How Does Modern Software Assist in Data Collection?
Clinical trial management software (CTMS) systems have helped streamline the complicated process of planning, performing and reporting clinical trials at every phase. Whereas they’ve been employed in pharmaceutical and biotechnology companies to aid their research, CTMS systems are also becoming important resources for research hospitals, physician practices, academic medical centers and cancer centers.
Following are some of the biggest advantages of CTMS systems for clinical trial research:
- Tracking Assistance: CTMS systems assist researchers to track participants, deadlines and milestones.
- Compliance Assistance: CTMS systems can be tailored to one of the four clinical trial phases to ensure clinical research procedures and workflows meet regulatory guidelines.
- Comprehensive Administrative Assistance: CTMS systems usually include budgeting, patient management, compliance with government regulations, project management, financials, patient management and recruitment, investigator management and compatibility with other systems used to collect patient data.
A New Software Platform Answers the Need for Standardization in Clinical Trials
Fewer than 40% of non-pharmaceutical clinical trials are adequately described. This is often due to poor data collection tools and the lack of standardization. A 2013 study on non-pharmaceutical interventions by Tammy C. Hoffman et. al. highlights the consequences of improper data collection: “If trial reports do not have a sufficient description of interventions, other researchers cannot build on the findings, and clinicians and patients cannot reliably implement useful interventions.” (Source: https://www.bmj.com/content/347/bmj.f3755).
This calls for a software platform that ensures data is collected in a systematic, reliable, standardized manner. Lumedi EDC is a clinical research data management software platform, developed in collaboration with clinicians and researchers, for clinical research studies, including clinical trials.
Lumedi EDC can assist in CTMS data collection. Here are some of its advantages for clinical trial research:
- Ease of use. Lumedi EDC is a cloud based platform. It can be run from anywhere, at a lower cost, and will keep all the data in one place.
- Compatibility with other tools. Lumedi mHeatlh can collect data from wearables such as ECG holters, insulin monitors and activity trackers.
- Quality of data collection. The software has been tailored to collect both quantitative and qualitative data on quality of life measures such as symptoms, functionality and physical, mental and social health.
- Integration. Lumedi EDC can be integrated to be compatible with CTMS systems for clinical trials of any size.
Proper data collection is vital for clinical trial research. Lumedi EDC is a powerful software platform researchers can employ with a CTMS system to ensure the highest quality of research. To learn more about using Lumedi EDC for clinical trial research, contact us today.