In a recent XClinical LinkedIn post, we mentioned a discussion with a mid-pharma/biotech leader who was not interested in partnering with an EDC solution vendor. This person said that they completely delegate the software selection task to their CRO partners, which is rather common in our industry. In this article, we will look at this from a different angle. Please do not hesitate to share your feedback!
Be Ready to Upgrade the Value of Your Clinical Data
Obviously, data has always been important in clinical trials, but the volume and sources of data are changing. In addition, cross trial metadata analysis is becoming more important. The data collection process is more complex due to the diversity of data sources and technologies. Clinical data can be a gold mine… Or a cash burner.
Other industries have been collecting massive amounts of data for years using multiple sources. For example, Google, Facebook, Amazon – and many of them, if not all, are watching the healthcare industry. The healthcare industry itself is changing: increasing demands for safety, patient centrism, artificial intelligence, regulation evolutions, global standards, etc. Not only the biopharmaceutical industry is impacted but also the medical device industry.
Remember, it takes a long time to bring a drug or medical device to market; in some cases, such as drugs and class 3 medical devices, it can take more than 10 years. And it’s not always a success!
During that time, a bio-pharmaceutical or medical device company will continually gather clinical and study related information on the product in development and make decisions about investment and strategic direction. You are therefore driving the future of your company… And the smaller you are, the riskier are the decisions.
If all the information is captured using a standard and consistent methodology, in an intelligently stored and formatted way, you can use the data to 100% of its capability. Literature says that only 30% to 60% of the total volume of information gathered during a trial is finally used for conclusion. But you never know what the 100% information could bring in the future, that’s where the shift is!
Be Ready to Upgrade Your Clinical Data Management Processes
Data management is one of the central activities in clinical trials and the electronic processing of data is continuously increasing, not only because it’s more reliable, easier, cheaper but also because it opens the door to new uses (current or future).
For your data management work, you can either do it yourself or externalize it to a CRO. Most of the time, externalization is the most efficient and cost-effective option as CROs often bring the expertise to capture robust data efficiently. You usually follow the recommendation of the CRO and use whatever system they deem appropriate. Let’s see the situation from a different angle. You are not an IT or DM specialist but imagine for a moment you want to make the decision about the software to be used. What could be the benefit of selecting your own EDC system and asking the CROs to use it? Read on to explore the benefits of an EDC preferred partnership model with us!
#1 – Build Expertise as a Basis for Value Creation
When using a single EDC vendor for all your trials, your company develops EDC system expertise. It allows your company to develop a culture of data standardization, sharing, central reporting, and seamless data integration.
Operationally, having a single EDC partner allows for better follow-up on system related issues and requests, participation in the evolution of the partnership and enhancements to your EDC vendor’s system. It also strengthens the exchange of information and expertise from both sides, ensuring joint growth and progress. A core group of internal staff, even if it is just one person, with a thorough knowledge of the EDC system enables the discussion of study related challenges between your team, the EDC partner, and the CROs. The internal expert keeps your team up to date as the system evolves and has the knowledge to support the integration of the EDC with other systems such as reporting, wearables, e-consent, and e-diaries. This model facilitates communication between the parties and ensures openness and transparency. Information is readily shared; it does not go into a black box.
As your expertise grows, you are ready to create value in operational savings and improve vendor management, let’s see how.
#2 – Operational Savings Based on Inhouse Expertise
In all your studies, there are similar elements or even identical information that is always collected. But, when using multiple CROs for any reason, you cannot guarantee that what you have developed in one study can be fully re-used for the next one. In addition, even if you have a single partnership with a CRO, given a certain level of employee rotation and turnover, you cannot guarantee that the CRO will fully benefit from previous study experience. Only you can ensure that you leverage your product expertise and study experience(s) moving forward.
Sharing knowledge within your company and applying lessons learned becomes easier when using a single EDC system partner for all your clinical trials. Your knowledge management efforts will enable:
- Creation and reuse of forms and templates that entirely suit your needs
- Faster eCRF set-up because of your mastery of the system
- Ensure that all CROs are using the same specifications of the datasets to avoid ambiguities and increase data quality across all your trials
- Facilitate access to data and accelerate data cleaning procedures (e.g.: responses to queries) and study closing
- Implementation of data standards to simplify data flow within your company
- Uniform approach to data collection, also improving the work of other external functions, e.g. monitoring or medical writing
- Centralized and standardized reporting
- Effective discussions of data requirements and workflows with CROs
- Facilitate data transparency and sponsor oversight procedures, inclusive of regulatory requirements
- A better understanding of the requirements to make data compliant with regulations
Access to an efficient knowledge management system including the creation of libraries, standardized CRF pages, forms, and more is key. Initial set-up of the EDC system takes time, but in the long term there are major benefits derived from these efforts. These include improved data quality, data reliability, data visibility, and data accessibility. It allows you to focus on your clinical trial strategy rather than on the operational implementation.
#3 – Streamlining Vendor Management
Working with a single EDC vendor for all your clinical trials provides a stronger and more personalized client-vendor relationship. This relationship will pay dividends in the long term. For example, as a key customer of XClinical, you will have an impact on the evolution of our Marvin product suite. As part of that relationship, you will have access to a dedicated account manager who knows you and your needs; not only working with you on the financial and business aspects but also playing the role of advocate for your company’s requirements. You become a partner, not just another client, with better service and faster responses to challenges.
Working with a single EDC vendor streamlines the invoice management process, which is a clear cost saver (for example, one invoice per month for all studies, no matter how many CROs you use). Once the process is set, you no longer need a complex operational review and approval process for invoice management, reducing the time (and money) spent on this activity as well as increasing transparency.
Working with a single EDC vendor also opens the door to volume efficiencies and discounting schemes, which would not be available without a preferred partnership. Keep in mind that data management costs (system and FTE) can represent 30 to 50% of most trial budgets.
Working with a single EDC vendor could also benefit your preferred CRO. Independent of size, or whether your CRO has an internal EDC system, training them on another provider may benefit them in the long run. The experience they gain using a robust EDC system can be offered to future clients. Not only you ensure that your eCRF will be built according to the latest system capabilities, but also you will open the door for your partner CRO to do more business.
Working with a single EDC vendor could also optimize the support for your study. Sometimes, your preferred CRO may need local support or specific expertise on a challenging study. If you have direct access to and understanding of the data management system, you can easily partner with multiple CROs to meet your trial’s goals.
Working with a single EDC vendor could also save time for your QA, Operations and Vendor Management departments. The burden of vendor selection, auditing and SOPs is reduced – if you select one unique EDC vendor, these tasks will be done once with minimal repetition.
How to Select a Partner?
Now that we have reviewed a few of the potential interests in selecting one unique EDC vendor, the question is: how to select the best one?
- Make size a factor – It’s the same as with selecting a CRO. Pick the partner that is right for you, not too big, nor too small. Though larger companies may have a global footprint, they may not be able to provide the same level of flexibility, reactivity, innovation or expertise that a smaller company can offer. Surely, big companies are robust, provide reliable technology and are investing massively, but at what price? When selecting an EDC vendor, select the one that fits your size, growth and budget, not the very first one you find or the most visible.
- Look for flexible software and teams – Technology changes constantly and even if global associations and groups are trying to foresee the future, we never know what tomorrow will bring. 10 years is a long, long time in software world. Focus on the most flexible and visionary company… and software.
- Pick the right business model – A SaaS company is preferred to a software as a product company. Software as a Service is just that, a service that manages all aspects of the use and maintenance of the software. It ensures that the software is always up to date and on top of innovation. With Software as a Product, you purchase the product and are then responsible for all software upgrades, troubleshooting, as well as associated hardware that the software is installed on.
- It must be compliant! – Select your partner based on how the system meets and exceeds regulatory and security requirements to ensure that your data collection and storage are compliant.
- Match the company culture – Choose a company whose culture matches your own. Is the company focused on innovation? Security? Robustness? Openness to change? The perfect match is essential!
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