Managing trial data through paper-based case report forms and spreadsheets are no longer enough for veterinary clinical research organizations (CROs).
CROs managing trial data through paper case report forms and spreadsheets might be dealing with:
With pharmaceutical sponsors demanding faster timelines, stricter regulatory compliance, and an increasing need for real-time visibility into study progress, traditional paper-based workflows simply don’t fit today’s needs.
Traditional CROs rely on paper CRFs and spreadsheets. This leads to concerns from sponsors on data integrity and delivery speed, struggles in justifying timeline projections, and them losing the competitive edge over an evolving space. Advanced and modern CROs avoid these issues by deploying EDC systems. These systems are designed to help them maintain long-term pharmaceutical partnerships, ensure data quality sophistication, and ultimately realize premium pricing.
Implementing EDC systems isn’t just about matching pace with modernizing technology—it helps CROs increase operational efficiencies, optimize costs, and ensure they meet evolving regulatory expectations within accelerated timelines.
There are three questions that EDCs help competitive CROs answer “yes” to.
EDCs become the starting point of a connected data ecosystem, accelerating timelines, enabling data visibility and streamlining data management along with mobile apps. The key difference it brings is the "real-time validation."
Instead of discovering data quality issues during monitoring visits or database lock, EDC systems help teams catch issues instantly, while the patients are present, and the source documents accessible.
Let's talk about the benefits that EDC offers veterinary CROs, based on documented implementations.
With paper-based workflows, delays get built-in. With EDCs the database locks faster, eliminating the entire cycle of multiple transcription rounds and queries in paper-based workflows. These systems allow data to be directly entered into databases during patient visits while validation rules help catch issues in real-time. Queries raised get resolved while the source documentation is fresh, reducing the time it takes to database lock by 30-50% and ultimately accelerating days-to-market.
Manual transcription introduces predictable errors like understanding handwriting, decimal point shifts, skipped form fields and data being entered in wrong patient records. This affects data integrity in regulatory settings, and invalidates entire studies.
Automated validation in EDC systems build regulatory compliance and accuracy by avoiding errors with:
ACROs operate on thin margins. Paper workflows don’t help that situation because of the hidden costs that come with printing CRF pages, shipping forms, managing version control, physical storage, resources for transcription, and source document verification.
With EDC, ACROs can negate majority of these costs with remote monitoring alone, increasing profitability and efficiency.
Every data point in EDC systems come with:
These help immensely during inspections, as CROs can easily satisfy FDA 21 CFR Part 11 and VICH GCP requirements with complete, digital records instantly instead of pulling binders of manual logs and hoping that the signatures are legible. It showcases operational maturity that is highly valued by pharmaceutical sponsors.
Let’s talk about how integrating mobile apps with EDC helps in clinical research.
Field studies include client-owned animals, who are at various locations like veterinary practices, farms, and private homes. This introduces various challenges and create compliance issues like:
This is where mobile apps improve adherence and increase data completeness. They can transform owner engagement by delivering medication reminders, assessment prompts, and data entry forms directly to smartphones. Additionally, the monitoring activity or behavioral data from wearable devices can sync directly with mobile apps to build objective measurements. This helps CROs to build richer datasets than paper-based workflows.
Mobile apps architectures need to enable offline functionalities. This enables data entry even without connectivity status and automatically syncing to central databases when the network is available.
Architectural capabilities like these allow CROs to realize all the benefits of EDC systems even when they include rural veterinary practices, livestock facilities, and remote field sites in their studies.
Enforcement of compliance protocols can be built into mobile apps with scheduled assessments, required field completion, and automated reminders. Features like these help CROs prevent deviations proactively, by guiding users about what is required in real-time.
Many CROs see the full vision of a completely paperless operation with validated EDC systems but think “Where do we start” or “We could never implement that.”
This is where Cambridge PetTech experts would say starting small and scaling gradually with an expert is the best way forward. We propose a Crawl-Walk-Run approach to this.
Here is what we mean by that.
Begin by implementing basic EDC functionalities for one study. These could be:
By implementing EDC functionalities to anyone of these use cases, CROs could learn about:
The investment needed in this stage is just for the pilot licensing and implementation support.
Once the concept is proven, the EDC systems could be expanded to more studies with enhanced features. This could be:
At this stage, CROs can build confidence in what is working with:
After CROs validate the value being added by EDC systems in smaller deployments and optimize them for their unique studies, CRO leaders can consider comprehensive implementation.
EDC and mobile applications are not just about upgrading. They focus on eliminating what no longer works in data collection across veterinary clinical research, such as manual transcription delays, data quality issues, endless query cycles, and paper-based audit trails that are scrutinized by regulators. They are no longer an option but a genuine solution to ensure that CROs stay ahead of the curve while optimizing processes to realize cost efficiencies and increased productivity.
Just because a partner works in technology does not mean that they would understand how veterinary research operations work. They could miss out critical nuances in regulatory expertise with veterinary-specific compliances, functioning of existing lab systems, understanding what processes need to be prioritized to maximize efficiencies and experience in veterinary clinical trials.
With over 25 years of data engineering and compliance expertise, Cambridge PetTech exclusively focuses on enabling tech solutions for pet and animal health industries. We understand what each CRO needs and build custom, scalable EDC solutions, applying our proven crawl-walk-run methodology.
Let's talk about what your CRO specifically needs. Schedule a call with our senior leadership and they will help you identify the best starting point for your trials, understand realistic timelines and resources needed, and create a no-obligation implementation roadmap, tailored to your operations.
Questions? Email us: sales@cambridgepettech.com
