Can Next-generation Technology Empower Sponsors to Bring Back Clinical Trial Operations In-house?
The idea of working with Contract Research Organizations (CROs) is not new. In fact, its roots can be traced back to the 1940s and 50s, but over the years, CROs have become central to clinical research. According to Research And Markets, the overall CRO market is slated to touch US$ 72.1 billion by the year 2027, and it is expected to grow at a CAGR of 7% between 2020 and 2027.
Cost-saving has been one critical aspect that has worked in favor of outsourcing work to CROs.
Additionally, it also makes sense because sponsors sometimes partner with multiple CROs (in different geographies) to get access to a variety of gene pools.
Of course, sponsors continue to be responsible for all regulatory requirements even when they outsource to a CRO. It is only the operational risk that gets “outsourced” for a third-party provider to handle.
Clinical Research: A Complex Process
Drug development is a very complex process needing several years of upfront investment, financial wherewithal to handle failures, and the risk-taking ability to pursue continued research.
Over the years, the increased regulatory scrutiny to ensure patient safety and protect animal rights have also added to the complexity.
In such a scenario, CROs provide pharmaceutical and medical device companies with support and services on a contractual basis to facilitate the development of the drug or device. Their role could be end-to-end, right from conception to approval, or limited to specific jobs such as clinical trials.
For instance, during the pandemic, good CROs were able to leverage next-generation technology to conduct virtual clinical trials, while following new COVID-related regulations.
In fact, according to a McKinsey report published in October 2020, several clinical trials had been suspended in the early days of the pandemic. But once it was clear that this couldn’t go on and clinical trials had to restart, virtual trials became the norm.
More than 50% of the interactions between the lead physician and patients were done virtually as against 8% pre-pandemic.
At ComplianceQuest, we recently published an eBook titled “Virtual Clinical Trials: Everything You Need to Know”. The book covers the following topics in detail:
- 4 Things to Consider Before Setting Up Virtual Clinical Trial
- Virtual Trials and Technology Enablement
- How will Decentralized Clinical Trials (DCT) Dominate 2021 and Beyond
- Benefits and Challenges of Virtual Clinical Trials
Broadly speaking, tools such as electronic consent, telehealthcare, remote patient monitoring, and electronic clinical outcome assessments (eCOAs) are being used by investigators to stay connected with trial participants (without in-person visits).
The role of technology and a next-generation Clinical Trial Management System (CTMS) like the one we offer at ComplianceQuest has become extremely critical to streamline clinical trial operations.
The Advantages and Disadvantages of Using a CRO
Cost and time savings rank top amongst the benefits of outsourcing to a CRO. Being ready with an experienced team also means that the CROs can start the trial the moment the contract is signed with the sponsor. A research organization with international experience can also be an asset in getting regulatory approvals in different countries.
However, outsourcing is not without its challenges. Being unable to directly monitor and supervise the research or trial process means letting go of operational control. In case of any issues, the sponsor is still responsible and will have to bear the brunt of regulatory penalties and damage to its reputation.
To prevent this, the sponsor needs to conduct multiple audits of the CRO and make sure it is the right partner. Confidentiality of intellectual property is a serious risk when outsourcing to a CRO and so drafting the right agreements to minimize the risks is an important step.
In addition to this, ensuring regulatory compliance during the research process, having the skills to recommend an alternative course of action in case of any non-conformance, etc. will still be the sponsor’s responsibility.
The big question is: should sponsors consider moving certain clinical research processes in-house? For instance, with access to the right technology, can virtual trials be managed directly by sponsors? With technology now accessible and affordable, are we going to see more of this?
Technology – The Real Differentiator
Digital transformation of clinical research processes has been happening for a while now, but the pandemic certainly accelerated technology adoption.
According to CB Insights, there’s a wave of technology disruption that is happening in the clinical trials segment. We’re seeing the adoption of IoT devices to monitor trials, AI-enabled solutions for data privacy and protection, and machine learning for processing of Electronic Health Records (EHR).
Some of the benefits of this technology adoption include:
- Nearly 5,000 clinical trials were conducted for testing life-saving treatments and vaccines to treat COVID-19
- Research organizations were able to increase the no. of patients (COVID-related) who were ready to enroll for trials by over 80%
With the use of emerging technologies such as IoT and AI/ML, clinical trial processes have become more agile, adaptive, and efficient. Success rates have gone up as well.
A Clinical Trial Management Solution such as the one from ComplianceQuest enables end-to-end management of trials.
Such a solution not only benefit CROs to harmonize their enterprise-wide workflows, but also helps sponsors get a unified view of data from all research sites — located anywhere in the world.
Specifically, it delivers the following benefits:
- Ensures data quality across sites
- Delivers time and cost savings
- Enables the seamless management of all workflows and data flows
- It streamlines the management of sites, patient enrollment, document management, event tracking, milestones, site visit reports, finances, inventory and more
- Real-time data visibility across the trial lifecycle
- Enables compliance with Good Clinical Practices (GCP), 21 CFR Part 50 and 21 CFR Part 11.
Now, with such a solution, a sponsor can consider bringing in-house some aspects of research, a trend that is catching up in the industry.
Larger sponsors are setting up labs and hiring employees to initiate tech-enabled CRO services in house. If you are a sponsor looking to do this, we believe CQ CTMS is an ideal solution to streamline your clinical trial management workflows.
To know more visit: https://www.compliancequest.com/online-demo/