Approvia for IIS Concept Review

Streamline review and approval for Investigator-Initiated Study concepts — all while reducing risk.

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Approvia

Is your IIS submissions process stuck in the past?

Manual medical affairs workflows aren’t built for the complexity of today’s research landscape.

❌ Inefficient manual tools

Medical affairs manually manages submissions with spreadsheets, emails, and shared drives.

❌ Slow, siloed reviews

Manual review process for IIS concepts are slow, fragmented, and difficult to track.

❌ Delayed research impact

Approval delays hurt real world evidence (RWE) generation and slow time-to-market.

❌ Compliance gaps

Regulatory compliance suffers from lack of audit-ready documentation.

Get smarter, faster IIS approvals with Approvia

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Approvia streamlines concept review and approval for investigator-initiated studies — replacing manual workflows with automation, visibility, and audit-ready compliance.

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  • Centralized workflows

    Ditch the spreadsheets and inbox chaos. Approvia replaces manual tracking with structured, role-based workflows tailored to your SOPs.

  • Faster, coordinated approvals

    Auto-assign reviewers, track progress in real time, and eliminate bottlenecks with smart dashboards and built-in reminders.

  • Accelerated time-to-approval

    Get investigator-led research moving faster by reducing cycle times and improving visibility at every step of the process.

  • Audit-ready documentation

    Log every action with full traceability — ensuring inspection readiness and alignment with FDA, EMA, and ICH guidelines.

From submission to approval — no chaos, no gaps

Approvia guides IIS concept submissions through a structured, auditable workflow aligned with your internal SOPs.

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Powerful features that streamline IIS reviews

Smart intake forms

Automatically route submissions based on your unique SOPs.

Real-time dashboards

Track approvals and identify bottlenecks in real-time.

Reviewer assignments

Automatically assign reviewers based on specialty or region.

Audit tracking

Ensure compliance and get visibility at every step with full audit trails.

No-code configuration

Customize workflows and user roles without pulling in IT support.

Seamless integrations

Connect your existing tech stack for continuity across systems.

Why BP Logix?

Our flexible, scalable process automation solutions empower life sciences team to operate better and do their best possible work.

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Built on a powerful low-code platform

With Process Director, you get a process engine that works every time.

 

Easily scale to support new processes

There's endless possibilities for automating and optimizing other processes, whether you use one of our pre-built use cases or create your own.

Cost-effective platform licensing

Enjoy the greatest bang for your buck as you create more new processes.

 

We're more than a SaaS provider

Get the convenience of SaaS with the added luxury of a consultative business partnership. We’re there to support you every step of the way.

Enjoy the best of both worlds

Get the speed and affordability you need, plus powerful customization options not available in competing regulatory affairs solutions.

80% pre-built to 20% configurability

Approvia offers the perfect balance of pre-built functionality and flexibility, with 80% of the solution already built and the remaining 20% configured to your organization's specific requirements.

 

Free up your team to focus on science

Start a conversation today to learn more about Approvia for IIS.
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With Approvia, you can:

  • Accelerate time-to-approval

    Eliminate bottlenecks caused by email-based tracking and manual follow-ups.

    Approvia’s automated workflows and smart reviewer assignments help teams move faster—so promising investigator-led research gets the green light without unnecessary delays.

  • Ensure end-to-end compliance

    Maintain a full audit trail from submission to approval.

    Every action is tracked and timestamped, making regulatory inspections and internal audits seamless and stress-free.

  • Gain real-time visibility

    Keep all stakeholders informed with role-based dashboards and live status updates.

    Approvia gives your team clarity on exactly where each submission stands, reducing uncertainty and missed deadlines.

  • Tailor workflows without IT

    Quickly adapt the review process to your SOPs — no coding required.

    Whether you're supporting 10 or 100 IIS submissions a year, Approvia scales with you and fits your existing approval structure.

Number of documents + review and approval silos + number of stakeholders = risk of errors, rejections, and lost revenue

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