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The only AI-powered Middle Office Platform that unifies PLM, QMS, EHS, and SRM into a single, intelligent solution
Product Lifecycle Management
Enable cross-functional collaboration and accelerate your product lifecycle with a cloud-based platform for innovation
Design Process and Quality System Development Tools in Product Lifecycle
Design Quality
Get full visibility over your product design processes and make collaboration easy to get your products to market faster, compliantly
Design Quality: Connecting Design to Documentation
Complaints Management
Transform customer complaints to valuable sources of insights for continuous improvement through smart automations and integrated regulatory reporting
Challenges with Triage and Investigation in Complaints Management Process
Document and Learning Management
Say goodbye to paper! Modernize your processes with connected document, training, and change management
Manufacturing Challenges and Industry Trends Towards Digital Transformation
Quality Management
Transform quality into an enabler: boost efficiency, increase satisfaction, and trim costs with a fully connected, AI-powered quality management solution
Frost Radar for Quality Management Systems Names ComplianceQuest Leader
Risk Management
Enable risk-based thinking throughout your quality processes with a fully integrated risk management solution
Automation of the Risk Management Lifecycle with AI and Analytics
Supplier Management
Increase supplier performance, reduce costs, and streamline your supply chain with integrated supplier quality and collaboration tools
The Ultimate Guide to Next-Generation Supplier Management [e-Book]
Safety Management
Identify and minimize safety events. Prevent accidents, safeguard workers, and ensure their well-being and health
Safety Essentials: Key ‘Must-have’ Components for Safety Management at Any Enterprise
Environment and Sustainability
Proactively and accurately monitor and measure your company’s impact on the environment to improve performance and reach your environmental and sustainability targets
Environmental & Sustainability Management
Electronic and Automated Approach to Audit Management
Managing the Tools of the Trade
Manage Operational Risk Tracking, Evaluation, Mitigation and monitoring
Leveraging CAPA for Continuous Improvement
Ensure your laboratory is compliant with systematic and efficient laboratory investigations
Incident Reporting and Management
Organization, Collaboration and Governance for Efficient Changes
Conduct smart management review meetings with a tower of data to improve your quality and safety systems
Gain 360 degree vision into enterprise wide Safety risks
Enhance Safety and Compliance with Smarter Chemical Management
Ensuring Quality across Departments & Locations
Partner With Suppliers And Vendors To Improve Quality And Safety
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Streamline Permit Management and Ensure Compliance
When Learning Propels Organizational Growth
Improve efficiency, productivity, and compliance with a solution designed for today's diverse workforce learning styles
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Relevant Information within reach - Always.
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ComplianceQuest covers the whole spectrum of customers, industries and regions across the world. Whether it is a small, medium or enterprise sized manufacturer, companies choose ComplianceQuest for its end-to-end Product Lifecycle, Quality, Safety and Supplier Management Solutions.
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Leveraging AI to Create a Safer Workplace Environment
Why an EHS Solution Built on Salesforce Works Better Than One Built on AWS or Azure
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Humans: The Real Superheroes of Artificial Intelligence (AI) in Quality Management
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Aphria (now Tilray) CIO talks about their implementation of ComplianceQuest, Rootstock and Salesforce
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Data-driven Safety – Strategic Resources for Monitoring of Key Performance Indicators
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American Society on Quality World Conference on Quality and Improvement
04 May, 2025
Denver, CO
About
About ComplianceQuest
Transform to a fully connected business with a next-generation AI-powered Product Lifecycle, Quality, Safety, and Supplier management platform, built on Salesforce.
Our connected suite of solutions helps businesses of all sizes increase product, quality, safety, and supplier as they bring their products from concept to customer success.
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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.
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 drug or device development. 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:
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.
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 DifferentiatorDigital 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:
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:
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/
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In June 2021, McKinsey published an article on the decentralization of clinical trials. The report…
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