Validation and study data quality should be thought of as iterative and continuous workflows. Yet, many teams still work within usage models and contract terms that make it harder to validate for rules and conformance checks as often as needed.
eDataValidator was designed to change that. Built by PointCross, and used for well over 100,000 study data packages, it provides limitless SDTM, ADaM, and SEND validation with transparent pricing and full FDA, PMDA, and CDISC compliance. Teams can validate continuously, across every stage of study build and submission preparation, without worrying about caps, meters, or overages.
Validation That Enables, Not Restricts
Regulatory authorities already publish their conformance rules, and CDISC defines the data standards. The urgency of industry’s need has been made clear: compliance should not equal cost. So, eDV applies these standards accurately, efficiently, and affordably, with extended rules checks to reduce false positives and errors.
Compliance should not equal cost.
When validation processes are tied to usage limits and enterprise contracts that can discourage frequent checks, this makes validation a budget decision rather than a quality practice. CRO and Sponsor pharma customers have re-designed their SOPs and workflows around limitless validation and succeeded at more iterative, quality-driven study builds while using eDV.
What Makes eDataValidator Different
- Unlimited Validation- Teams can run validation as often as they choose. Every change, every update, every new dataset can be verified without triggering new costs. eDV offers a custodial ownership model without needing additional licenses. Continuous validation means issues are caught earlier and submissions are cleaner.
- Transparent, Predictable Pricing- Despite a universal need for validation, we recognize that a pricing model may not be “one-size-fits-all”. Consultants and 3rd party data management providers often subscribe to eDV on an individual or group user basis, while larger enterprise subscribe based on anticipated number of studies. Either way, eDV has driven over 50% cost savings and resulted in greater flexibility and custodial use of the validation tool and its myriad features.
- Comprehensive Coverage Included- FDA Validator Rules, PMDA conformance, and CDISC standards are all part of the core offering. The latest published rules are rigorously tested, validated, and rapidly pushed to eDV.
- Flexible Deployment- eDataValidator runs securely in the cloud or provides users the option of using a local desktop application, using the same validation engine in both environments. Teams can choose the setup that fits their collaboration and IT needs.
- Integration Ready- A command-line interface allows for automated and scheduled validation within existing data workflows. eDataValidator also connects easily with Xbiom’s Metadata Repository (MDR) for standards management and governance to aide and assist programming teams.
- CFR Part 11 Compliant- Complete audit trails, electronic signatures, and IQ/OQ/PQ documentation are standard. For over a decade, eDataValidator has supported submissions with zero regulatory rejections.
Proven in Real Submissions
eDataValidator has supported successful IND, NDA, and BLA submissions across oncology, rare disease, CNS, cardiovascular, and metabolic indications. It is used by organizations of every size, from emerging biotechs to global pharmaceutical companies and CROs managing multi-sponsor programs.
These teams rely on eDataValidator not just for compliance, but for confidence, knowing that every dataset can be validated as often as needed to maintain quality throughout development.
A Better Fit for Modern Teams
Many data management and programming teams rely on long-established validation tools because of adoption and familiarity. That choice can make sense for some organizations, but when regulators actively use multiple validation systems, it is no longer (and should never have been) a game of anticipating validation results.
Rather, conformance checks with explainability in reviewer guide documentation permits more robust data standardization including for use cases such as exploratory endpoints, custom domains, or novel biomarkers. Custom, sponsor-defined conformance rules targeting novel variables or domains are all straightforward when working with eDV.
So if you are an emerging biotech focused on cost of operations, a CRO managing multiple sponsors, or a submission lead who wants validation to be part of every QC cycle rather than an occasional checkpoint, it may be time to consider a different approach.
eDataValidator offers the same regulatory reliability with a modern, scalable model that fits how today’s teams work. It aligns validation frequency with data quality goals, not budget restrictions.
Just Hearing About Us Now?
PointCross has served the life sciences industry since 2009, focusing on engineering excellence rather than marketing volume. Our growth has come from recommendations: sponsors, CROs, and consultants who have experienced the benefits first-hand. As our eDV user base grows, we are now making eDataValidator more visible so that more teams can take advantage of its flexibility and cost transparency.
Try eDataValidator Yourself:
You can evaluate eDataValidator directly with a 30-day free trial. No credit card is required, and the latest regulatory rule sets are included in a near-production grade instance (we can help with integrating your MedDRA, WHO-DD, SNOMED, etc. dictionary licenses for your own organization’s use).
Most teams begin validating production datasets in the first week and quickly recognize the value of unrestricted, continuous validation.
Questions? Contact edvsupport@pointcross.com