Stability

Bring protocol-to-schedule orchestration and study readiness together to keep stability studies on track

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Keep stability studies aligned from plan to execution

Stability studies aligned with ICH Q1 and Q5 guidelines, underpin shelf-life and submission confidence by tracking performance over time across controlled conditions, timepoints and configurations. But when the protocol, pull schedule and execution records are scattered across spreadsheets, email and documents, teams lose visibility.

Missed pulls, inconsistent records, rising rework and inspection risk point to a deeper problem: stability execution is still coordinated manually across tools that were never designed to stay aligned over time.

The IDBS Polar platform closes this gap by governing stability execution end to end. Study setup and pull schedules are defined up front, execution and exceptions are tracked in context, and data stays connected as studies evolve. With continuous alignment across planning, scheduling, execution and reporting, teams avoid missed pulls, reduce rework, and deliver right‑first‑time stability execution at scale.

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Reduce reporting time by 80%*

See how IDBS Polar delivers aligned, visible and orchestrated stability across every timepoint

IDBS Polar brings stability protocol definition, study setup and execution together—so stability studies remain consistent, controlled and traceable from first timepoint to final pull.

Stability studies are defined early, but executed over months or years. Without a connected system, gaps between protocol design and day‑to‑day execution quickly lead to missed pulls, inventory issues and manual reconciliation.

See how Polar supports stability teams to:

  • Define structured stability protocols
    Capture conditions, timepoints, assays and specification limits in a clear, standardized structure—creating a reliable foundation for long‑running studies.
  • Design complete study and sample strategies
    Define sample quantities, overage and pull‑and‑test thresholds up front, ensuring execution remains accurate and predictable across all timepoints.
  • Execute stability workflows with confidence
    Coordinate materials, samples, assays and inventory through integrated, protocol‑driven workflows—ensuring each pull follows plan, with traceability built in.

See how Polar reduces downstream issues while providing clear, timepoint-specific guidance and controlled execution across stability studies.

LL1 Full Stability Thumb

IDBS Polar keeps stability studies aligned from protocol initiation through ongoing execution and results review—aggregating schedules, activity and data in a single, traceable framework.

With ongoing studies, maintaining alignment between approved protocols, execution activity and evolving results is critical. Without a unified view, it becomes difficult to track compliance, detect execution risks early or understand trends across timepoints.

In this short walkthrough, see how Polar helps teams:

  • Initiate studies directly from approved protocols
    Create stability studies from approved protocols and products, automatically populating study structures, schedules and metadata to maintain alignment from planning through execution.
  • Monitor pull schedules and execution compliance across studies
    Track scheduled versus actual pull and test activity across multiple stability studies using calendar-based and tabular views, enabling early identification of deviations, exceptions and execution risk.
  • Aggregate and review stability results across timepoints
    Bring stability data together across timepoints, conditions, orientations, assays and samples in unified views that preserve full context and traceability to underlying records.

See how Polar maintains alignment and visibility across stability schedules, execution activity and results — enabling proactive compliance monitoring and confident review across timepoints.

LL2 Full Stability Thumb

Take the next step

Want to go deeper into why stability studies slip—and what leading organizations are doing to regain control? Read the blog “From protocol to pull: why stability studies slip – and how to regain control“.

If you’d like to explore how Polar supports governed, right-first time stability execution, aligned to ICH Q1 and Q5 in your environment, contact us to schedule a conversation or demo or download the flyer.

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*Customer data on file at IDBS. This result was originally obtained using IDBS E-WorkBook; IDBS Polar delivers the same or higher gains as IDBS E-WorkBook in a like-for-like implementation, with added value from advanced analytics, AI/ML and reporting.