The hidden cost of disconnected systems in biotech and the path to streamlined trials

Biotech companies push to deliver therapies at unprecedented speed. Too often, their own fragmented systems slow their progress, creating delays that no one can afford.

If you are a clinical leader or R&D executive, you know the cost.You have seen the spreadsheet patchwork, the duplicate data entry, and the costly errors that only surface during an audit. Is there a better way to run trials in this age? Absolutely.

But first, we need to talk about the real price of disconnection and why most teams are still paying for it.

The silent disruptors of clinical progress

Not all obstacles in clinical trials are visible.

Behind the scenes, silent disruptors, from fragmented data and legacy systems to misaligned processes, continue to slow progress. These hidden inefficiencies quietly drain time, budgets, and data quality, ultimately undermining trial outcomes.

Let us break it down:

• Delays: Fragmented systems often require manual data entry and reconciliation. This slows down site activation, protocol updates, and real-time decision-making.

• Errors: Double entry across EDC, CTMS, and ePRO increases the likelihood of transcription mistakes and misaligned datasets.

• Compliance risks: Version mismatches and incomplete audit trails can trigger regulatory red flags during inspections.

These are not just operational headaches, but a strategic risk. In a setting where everyday matters, even small inefficiencies compound into costly setbacks, delayed site activations, rising trial costs, and compromised data integrity.

Why does this keep happening?

The fragmentation of clinical systems isn’t accidental; it’s a structural consequence of how the industry has evolved.

Biotech companies often start lean, adopting tools as needed: one EDC for data capture, a standalone eTMF for documentation.

Each system solves a specific need, but most are not natively designed for seamless interoperability.

As trials scale across geographies and indications, this patchwork becomes harder to manage. Data lives in silos. Teams rely on manual workarounds, custom APIs, temporary bridges, and costly vendor coordination.

The result? A fragile digital infrastructure that slows decision-making, increases the risk of errors, and creates blind spots in compliance oversight.

The real cost, and the hidden one

It is easy to budget for licensing fees and vendor hours. It is much harder to quantify:

• The cost of FPI (First Patients In) delays caused by the randomization module did not sync with the site’s availability window.
• Lost data when a wearable’s outputs couldn’t map into the core EDC without manual transformation.
• The countless hours your data manager spends verifying fields that should have been unified at the point of capture.

Most teams fail to anticipate these costs. They are hidden in workarounds, normalized by legacy processes, and rarely tracked line-by-line. But they are real, and they are growing.

Delayed trials affect investor confidence. Missed milestones derail partnerships. Compliance risks threaten the very viability of your assets.

In drug development, every day lost comes with a steep price tag. Recent research from the Tufts Center for the Study of Drug Development estimates that a single day of delay equals ~$500,000 in lost prescription drug or biologic sales, while the direct cost of running a clinical trial day is ~$40,000 for Phase II and III studies. 1

These numbers put into perspective just how costly “invisible” inefficiencies can become—whether it’s a delayed FPI, a site activation bottleneck, or a randomization module out of sync with site availability.

And that is why biotech requires unification, not just integration. Integration connects systems. Unification dissolves the boundaries between them. Think of it as the difference between having adjacent puzzle pieces versus one seamless image.

Instead of relying on fragile, temporary bridges, a unified system such as oomnia goes beyond simply connecting modules. It provides true integration, bringing data, processes, and oversight into a single environment designed for scale and interoperability.

How oomnia fixes the fragmentation

oomnia is not just a toolkit. It is an operating system for modern trials.

By unifying core modules (EDC, eTMF, CTMS, RTSM) and patient-facing tools (ePRO, eConsent, eSource, eCOA), oomnia creates a single web-based environment that reduces reliance on piecemeal integration.

• A single system, a single point of access, and a single source of truth for all your clinical data
  Fragmented systems leave teams with multiple dashboards and conflicting data. oomnia provides a single access point built on one reliable source of truth.

• Real-time data flow that keeps trials aligned and responsive
  Using its advanced eSource capabilities, oomnia captures data directly at the point of care, whether from EHRs, wearables, or mobile apps, and routes them into your trial database in real time. No manual transcription. Data is updated continuously, ensuring accuracy without reliance on overnight processes.

• Smart design, zero redundancy
  Form duplication and reconciliation fatigue are eliminated through unified data capture. oomnia’s customizable workflows and drag-and-drop form builders let your teams tailor protocols across studies, without coding, delays, or retraining.

• Built-in compliance
  With audit trails, role-based access, and encryption protocols integrated into its architecture, oomnia ensures that every activity is tracked and every document is inspection-ready.

• Scalable, secure, and high-performance
  Thanks to a no-code infrastructure and interoperable core, sponsors using oomnia have reported:

• Up to 83% faster clinical trial set-up

• 50% fewer protocol deviations

• Up to 80% manual work reduction

Implementation, including setup and training, is typically completed in under 10 weeks.

Source: Based on client feedback linked to time efficiency gains in processes such as randomization and SDTM mapping. One client set up a trial with 5000 questions in significantly less time compared to one of the largest global CROs for the same trial in a different geography. Clients also reported receiving faster reports thanks to reduced manual labor and automated processes.

From friction to flow: a practical roadmap

So, what can biotech leaders do right now to address these challenges?

• Audit your ecosystem
  Where are the data handoffs? What requires manual reconciliation? Which tools are not yet interoperable?

• Calculate the hidden costs
  Include time delays, duplicate vendor fees, error remediation, and staff inefficiency.

• Expect more from your tech
  Do not settle for integrated silos. Prioritize unified systems with clinical logic at the core.

• Pilot a unified solution
  Start with one protocol, one site, one workflow, and measure the difference in activation time, data quality, and user satisfaction.

• Scale what works
  Once the benefits are clear, expand unification across programs, teams, and trial phases.

Final thought

The real danger is not that disconnected systems slow you down. It is that they become invisible. These inefficiencies are often accepted as just how things are. But they do not have to be.

oomnia shows what happens when we stop accepting fragmentation and start designing for flow. Eliminating fragmentation begins with adopting a unified system.

Begin your journey with oomnia.

References: 1 Smith ZP, DiMasi JA, Getz KA. New Estimates on the Cost of a Delay Day in Drug Development. Drug Inf J. 2024;58(5):855-862. doi:10.1007/s43441-024-00667-w. View on [PubMed]