The Top Line:
- More than 70 percent of clinical trials now use some form of EDC
- Cloud-based EDC platforms offer significant benefits for all sizes and types of organizations
- Selecting the best system for you requires careful due diligence in five key areas
If there is an EDC genie, he’s permanently been let out of the bottle.
Well over 70 percent of clinical trials now use Electronic Data Collection (EDC) in some fashion since the first systems appeared a decade ago. And even if the pharmaceutical and medical device industry is historically slow to adopt new technology, the ease, efficiency and cost-effectiveness of cloud-based EDC platforms are encouraging upgrades across the sector.
CROs and investigator site early adopters, particularly in the U.S. and Europe, are taking the next step in clinical IT’s evolution: They’re moving away from older proprietary, server-based EDC systems, spurred on by streamlined data collection that improves data security, quality and access. This trend is especially evident among small and medium-size sponsors, CROs and academic research institutions that lack the capital needed to purchase, install and maintain server-based systems. And the market has responded as EDC vendors have added cloud-based tools to their product and service suites.
With all the advantages cloud-based systems offer, how hard is it to make the switch? It depends. Any change in technology will require a transitional period during which you’ll experience some measure of disruption. The key, then, is to conduct your due diligence in a way that will shorten the “return to normality” and speed your ability to capitalize on the new system’s benefits.
Before we jump in, a quick reminder: As you consider the alternatives, ensure every step in making the switch is identified and assigned a time value that are then built into a master project schedule. The system and vendor you choose should have internal experts who can shepherd the transition to ensure it is as smooth as possible and preserves the integrity and compliance of your data.
Outlined below are five key tasks that need to be at the top of your checklist when reviewing vendor proposals.
1. Data Transition
A secure cloud-based platform should easily accept and convert clinical data from multiple systems and sources – including EDC, CTMS, legacy studies, clinical research organizations and even MS Excel® files. More advanced cloud platforms will enable clinical team members from across the organization – in different countries and in their native languages – to import and interact with data whenever and however they choose. This function can be especially helpful for smaller research organizations that participate in international networks or are partnering with similar counterparts around the globe.
Ask each vendor how its system supports validation and compliance, with a special focus on the following checklist:
- 21CFR Part 11
- 21CFR Part 5021CFR Part 54
- 21CFR Part 312
- 21CFR Part 314
- 21CFR Part 820
- 45CFR Parts 160, 162, 164
- EU GMP Annex 11
- FDA Guidance - Investigator Responsibility
- ICH E2A, ICH E3, ICH E6, ICH E8, ICH E9, ICH E2D, ICH E14
It’s also important to confirm that a vendor’s platform adheres to the following:
- 21CFR Part 11
- EU GMP Annex 11
- 45CFR Parts 160, 162, 164
- 21CFR Part 820
- FDA Guidance - Computerized Systems Used in Clinical Trials
- FDA Guidance - General Principles of Software Validation
- Any pertinent local and state regulations.
You also may want to ask whether a vendor is ISO-certified and has its FISMA accreditation.
These questions apply to any clinical system, whether it is cloud-based, hosted by a service provider, or installed on-site. Select an EDC system that is not validated out of the box, and your organization is on the hook to develop processes around your use of the system on your own.
3. Data Preservation and Security
Questions about the security of your data as well as its integrity and availability are natural when considering cloud-based systems. It’s critical that you confirm – in writing – that the provider you select operates a secure, hosted environment for your data to ensure uninterrupted access and performance.
It’s also important to ask where the data will be housed as well as the specific physical and electronic security measures the vendor uses. Further, you should ask the company to detail its encryption, data backup and disaster recovery protocols and verify how the data will be protected. If your data is located on a shared server, be sure to as how it will be isolated from other clients’ data. Most established EDC vendors whose products are used by the larger CROs and sponsors have this base covered in spades, so be sure to as about that “stamp of approval” when considering companies.
The growing international scope of clinical trials raises the question of who can and should have access to and regulatory control of your study’s data. It’s likely the answer may depend on where the trial is conducted. For trials conducted in the U.S. and another country, ensure you confirm if the data must be hosted locally in that country. If so, be sure to have the vendors provide verifiable data on how and where they would host the data locally. (And even if your trials are not currently conducted outside of your country, you should consider these types of regulatory issues if you plan to expand your research footprint.)
5. Beware of the Buzz
Using a cloud-based platform should promote ease of installation, training and use. Self-service design, scalability and pay-as-you-go arrangements are among the biggest advantages of these systems, especially for smaller research organizations.
But it’s critical to recognize there are different flavors of cloud installation – Software as a Service (SaaS), software applications available as standardized service over the Internet; Platform as a Service (PaaS), which provides functions for quick, cost-effective development and deployment of applications; and Infrastructure as a Service (IaaS), using virtual servers, which is the most basic form of cloud computing. Examine how each of these versions would fit your organization’s requirements and proceed accordingly.
You may come across providers that say they offer all the benefits of “the cloud,” but when push comes to shove, it turns out they offer something that’s not quite what was advertised (e.g., promoting a pay-as-you-go financial arrangement that actually requires you to sign up for a pre-determined spending commitment).
It’s also critical that a vendor offers you the opportunity to take the software out for a test drive in a “real” environment. Unless you and your team can see what it’s actually like to use the product to build and manage a study, you may end up on the wrong side of a contract. (And speaking of contracts, if you can find SaaS vendors who offer an option to “turn off the spigot” without penalty, you’d do well to give them extra credit in the selection process.)
Adopting a cloud-based EDC system is not only a smart move for clinical research organizations, it’s very likely inevitable, as well. The days of costly, enterprise-wide system installations are quickly coming to an end (along with long-term contracts that locked you in for multiple years, no matter what).
Making the transition a successful one requires careful and methodical due diligence on your part. Pointed questions, detailed requests and an emphasis on evidence-based performance must be the foundation of your selection process. When the reputation of your organization’s ability to conduct accurate and cost-effective research is on the line, the most important rule of thumb to remember is a familiar one: caveat emptor – let the buyer beware.
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