Innovations in digital technology have transformed and re-calibrated industries including life sciences and pharma around the world.
One of the main aspects of the pharmaceutical industry is clinical trials and clinical trial management system. The purpose of conducting a clinical trial is to identify drug efficacy while ensuring human safety.
The main challenges that pharma industries face while conducting clinical trials include the following:
Difficulty in patient recruitment, retention, adherence to the stringent laws, rigid clinical trial execution timelines, and ineffective monitoring the trial processes.
Moreover, the lack of streamlined clinical trial data management and ineffective reporting tools impacts effective management of dense patient data for regulatory purposes.
These challenges not only increase the time-to-market, but also result in operational inaccuracies and increase the overall cost of the trials. Lack of technology in clinical trial management causes a potential risk of human error, as well as protocol violations.
The cost of developing an approved drug is nearly US $2.6 billion, as said in a study conducted by Tufts Center for the Study of Drug Development. The pharma companies are striving to optimize the clinical trial management system by integrating R&D information and by deploying technology-driven tools.
A recent report published by Accenture - Digital’s transformative power across R&D, identifies the main three categories of technology that could transform clinical trials: cloud, analytics, and mobile.
Pharma companies need to adopt digital technologies in order to keep up with the pace of the digital age. The use of leading-edge technology in clinical trial management can address the challenges faced in the traditional clinical trial management system.
By leveraging technology in clinical trials, pharma companies can take informed decisions and optimize their processes. Therefore, driving scientific and operational success.
A report by Markets and Markets estimated that the Clinical Trial Management System will reach USD 920.2 million by 2021.
The report further reveals that the growth of the global CTMS market is driven by the following:
- The increase expenditure of R&D
- A rising number of clinical trials
- An increase in the number of medicine launches
- An increase of the customer base due to the rising adoption of CTMS solutions
The growth of the global CTMS market is restricted by the following:
- Lack of skilled professionals operating advanced CTMS
- Budget constraints of small and medium-sized companies
- Small CROs
Difficulty in identifying the right site and patient recruitment
It's imperative for pharmaceutical companies to identify the right sites for trials, whether virtually or physically. Ideally, the right site is where the disease is most prevalent and with the help of analytics, it becomes easier to identify it.
Prescriber 360, a leading Microsoft cloud platform provider in the pharma industry, well recognizes the needs of the industry and offers ClinSite360, the most advanced clinical trial management system built on Microsoft Dynamics CRM platform, to their clients.
Patient recruiting is the most crucial part of clinical trials. There are pre-defined protocols that state the inclusions and exclusions criteria. The recruitment of patients are done on the basis of this protocol.
For example, the oncology trial protocol requires that the patient (subject) who is going take part in the trial process shouldn’t have undergone any type of treatment.
Such as, radiotherapy or chemotherapy at least one month prior to participating in the trial. If the subjects do not disclose this, the trial outcome will suffer an adverse impact.
Thus, it's crucial to carefully scrutinize the subjects before recruitment. Electronic Health Records (EHR) will ensure that the right patients are recruited, resulting in accurate and effective trials.
With the help of digital technologies, it has now become easier to reach and involve more subjects that could reap the benefits of the trial process.
With the help of ClinSite360, the scrutiny process can be simplified. By building a centralized control system, experts can monitor and track the past track records of the subject. This will reduce the chances of failure, help in controlling the data in real time, and accelerates the speed-to-market.
Apart from this, result driven analytics can help organizations identify the risks associated with the trial process. Early identification of risks will help them address the problems proactively.
Due to the technological advancements in the clinical trial management system, it's now possible to use innovative solutions to improve the productivity and time-efficiency of the trial processes.
Site monitoring and management
By leveraging digital capabilities, organizations can effectively monitor the subjects and will allow them to identify any potential risks in real time. Human intervention and chances of errors can be significantly reduced by using digital tools that will flag the errors while ensuring data quality.
Digital platforms enable effective management of data. This reduces the chances of errors and improves the efficiency of trials.
For example, an automated quality check on a regular basis will monitor the performance and identify any protocol deviations.
By integrating and managing huge volumes of data digitally, an organization can accelerate the process in a scalable manner, retrieve data faster, and generate actionable reports.
It's important for all the teams that are involved in conducting a clinical trial to be aware of any progress and findings. A lot of times, the processes are interdependent.
By leveraging cloud-based infrastructure, organizations can seamlessly share data across all silos of the organization. Thus, resulting in ineffectual use of time and resources.
This will also enhance the time-to-market and optimize the operational costs.
Reports and insights
With the help of digital technology, companies can generate ad-hoc reports faster. This leads to better decision making and will improve the efficacy of clinical trials.
ClinSite360 comes with a pre-built data mart that provides robust reporting using Power BI and sophisticated and advanced visualization.
It's powered by Microsoft’s Cortana Intelligence Suite that provides an opportunity to analyze a large amount of clinical trial data and machine learning capabilities to reduce time and costs associated with trials.
At the end of the process, teams are required to verify the data and reports formed by them. With digitization, teams will be able to easily verify the reports and ensure that the reports are sent on time to the experts.
This will also significantly reduce the on-site visits of the experts and will allow them to concentrate on the R&D.
System driven checks, automated supervisions, and timely reported generations will strengthen the internal regulatory framework of clinical trials.
Technology-driven tools will ensure accurate reporting and timely submission to the regulatory authorities. This will save the organizations from the complex and stringent consequences of non-compliance.
Pharmaceutical organizations need to ensure that they are compliant with the requirements of 21 CFR Part 11 while implementing digitization initiatives.
Moving towards better outcome digitally
Once the pharmaceutical companies realize the potential that lies in the digitization of CTMS their processes with digital strategies, they won’t look back at the traditional approach.
By digitally transforming their clinical trial processes, enterprises can optimize their trials costs and boost profits.
Digitization will not only enhance the accuracy of the process, but also help create an internal framework that simplifies the regulatory procedures.
It's imperative to leverage technology in CTMS in order to overcome the challenges, improve patient experiences, and generate better outcomes.