Want to avoid your IND submission delays, eliminate tedious manual compliance steps, and oversight gaps with CRO partners? Key Solutions gives lean biotech teams the tools to streamline compliance management and ensure audit-ready documentation at every stage.

Prevent IND Delays

Keep all compliance documentation organized, complete, and audit-ready, ensuring regulatory submissions happen on schedule.

Close CRO Oversight Gaps

Centralize monitoring of outsourced studies to maintain full visibility, reduce compliance risks, and eliminate blind spots.

Eliminate Manual Bottlenecks

Automate routine protocol submissions, renewals, and approvals, so lean teams spend more time on science and less on paperwork.

Ensure Regulatory Confidence

Automatically capture every decision, amendment, and communication, creating inspection-ready audit trails and reducing FDA-related stress.
90%
Faster protocol approvals
100%
Audit-ready documentation
24/7
System availability and support

Why Biotech Firms
Choose Key Solutions

Submit INDs on time

Organize all compliance documents in one location to ensure timely submissions without delays.

Monitor CRO studies in real time

Track all outsourced research centrally to maintain compliance and oversight.

Prepare for FDA inspections effortlessly

Automatically document every protocol, amendment, and decision to stay inspection-ready at all times.

Automate routine workflows

Streamline protocol submissions, renewals, and approvals, allowing your team to focus on research instead of paperwork.

Provide transparent investor updates

Generate dashboards with accurate, up-to-date research progress and spending instantly.

Integrate research systems seamlessly

Connect various committee protocols, animal care, and other platforms to eliminate data gaps and inconsistencies.

Our Solutions

Transform your research compliance management and admin operations with our specialized solutions.

Eliminate compliance bottlenecks and ensure audit readiness across all research committees.

IRB (Institutional Review Board)

Optimize the IRB compliance process to minimize investigator, coordinator, and committee effort while ensuring stringent approval protocols and risk mitigation.

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IACUC (Institutional Animal Care & Use Committee)

Facilitate the review and monitoring of all animal research protocols, ensuring full compliance with IACUC regulations for both USDA and non-USDA species.

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IBC (Institutional Biosafety Committee)

Protect personnel, human subjects, and society from biohazards by efficiently reviewing research protocols involving carcinogens, infectious agents, and allergens.

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SCRO (Stem Cell Research Oversight)

Streamline the approval and documentation process for stem cell research, ensuring consistent oversight and compliance with SCRO guidelines.

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CSC (Chemical Safety Committee)

Simplify CSC compliance by automating protocol submissions, ensuring safer use of hazardous chemicals and stronger oversight in research environments.

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CS (Controlled Substances)

Simplify CS compliance by guiding research teams through complex regulations governing the use of drugs and controlled substances.

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RSC (Radiation Safety Committee)

Ensure safe and compliant use of radioactive materials in research through structured RSC protocol review and enforcement.

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PAM (Post-Approval Monitoring)

Facilitate regular inspections of approved protocols and swiftly implement corrective actions to ensure continuous compliance with established safety and research standards.

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IRB (Institutional Review Board)

Optimize the IRB compliance process to minimize investigator, coordinator, and committee effort while ensuring stringent approval protocols and risk mitigation.

IACUC (Institutional Animal Care & Use Committee)

Facilitate the review and monitoring of all animal research protocols, ensuring full compliance with IACUC regulations for both USDA and non-USDA species.

IBC (Institutional Biosafety Committee)

Protect personnel, human subjects, and society from biohazards by efficiently reviewing research protocols involving carcinogens, infectious agents, and allergens.

SCRO (Stem Cell Research Oversight)

Streamline the approval and documentation process for stem cell research, ensuring consistent oversight and compliance with SCRO guidelines.

CSC (Chemical Substance Compliance)

Streamline chemical substance tracking by automating compliance checks, reporting, and inventory management. This minimizes risks, ensures safety, and keeps your research in full regulatory compliance.

CS (Controlled Substances Compliance)

Manage the complexities of controlled substance research compliance with tools for navigating drug and controlled substance regulations.

RSC (Radiation Safety Committee)

Ensure the safe use of radioactive materials in research by enforcing strict safety protocols and reviewing all related research proposals through the Radiation Safety Committee.

PAM (Post-Approval Monitoring)

Facilitate regular inspections of approved protocols and swiftly implement corrective actions to ensure continuous compliance with established safety and research standards.
Increase grant opportunities and manage end-to-end administrative processes with transparent financial tracking and automation.

Grant Management

Streamline grant administration with an automated system for tracking applications, approvals, and compliance. This saves time, reduces errors, and ensures funds are allocated correctly and efficiently.

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COI (Conflict of Interest)

Simplify conflict of interest tracking with a digital solution that automates disclosure management, approval workflows, and audits. This reduces risks and ensures full transparency for all stakeholders.

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Post-Award Grant Management

Enhance post-award oversight by automating tracking, reporting, and compliance monitoring after the grant is awarded. This ensures funds are used correctly and compliance is maintained throughout the project.

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Grant Management

Streamline grant administration with an automated system for tracking applications, approvals, and compliance. This saves time, reduces errors, and ensures funds are allocated correctly and efficiently.

COI (Conflict of Interest)

Simplify conflict of interest tracking with a digital solution that automates disclosure management, approval workflows, and audits. This reduces risks and ensures full transparency for all stakeholders.

Post-Award Grant Management

Enhance post-award oversight by automating tracking, reporting, and compliance monitoring after the grant is awarded. This ensures funds are used correctly and compliance is maintained throughout the project.
Ensure animal research compliance and optimal facility management, as per USDA, OLAW, and AAALAC regulations.

IACUC (Institutional Animal Care & Use Committee)

Make animal research compliance easier by automating protocol reviews and tracking health records. This reduces administrative work while ensuring ethical and regulatory standards are met.

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LARS (Laboratory Animal Resources Software)

Optimize lab animal resource management with a streamlined software solution that tracks inventory, usage, and compliance. This enhances efficiency, reduces errors, and ensures better resource allocation.

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LAHS (Laboratory Animal Health and Safety)

Strengthen animal health and safety oversight with a centralized system for monitoring animal welfare, safety protocols, and compliance. This ensures humane treatment and minimizes research risks.

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IACUC (Institutional Animal Care & Use Committee)

Make animal research compliance easier by automating protocol reviews and tracking health records. This reduces administrative work while ensuring ethical and regulatory standards are met.

LARS (Laboratory Animal Resources Software)

Optimize lab animal resource management with a streamlined software solution that tracks inventory, usage, and compliance. This enhances efficiency, reduces errors, and ensures better resource allocation.

LAHS (Laboratory Animal Health and Safety)

Strengthen animal health and safety oversight with a centralized system for monitoring animal welfare, safety protocols, and compliance. This ensures humane treatment and minimizes research risks.
Utilize AI/ML and data analytics solutions to reduce compliance risks, maximize research outcomes, and increase opportunities.

AI/ML Integrated Services

Make animal research compliance easier by automating protocol reviews and tracking health records. This reduces administrative work while ensuring ethical and regulatory standards are met.

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Data Analytics

Facilitate the review and monitoring of all animal research protocols, ensuring full compliance with IACUC regulations for both USDA and non-USDA species.

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Data Infrastructure

Unify and streamline your data management with our comprehensive data infrastructure services, ensuring your data is accessible, secure, and consistent. Integrate disparate data sources into a single platform to improve data integrity, governance, and facilitate smarter business decisions.

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Hosting

Simplify your hosting experience with our reliable and scalable hosting services, offering robust security, seamless performance, and compliance. By trusting us with your digital infrastructure, you can focus on innovation and growth while we ensure your applications run optimally and securely.

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AI/ML Integrated Services

Accelerate the ethical review process with a simple system to manage submissions and track compliance. This ensures faster approvals and keeps everything aligned with regulations.

Data Analytics

Facilitate the review and monitoring of all animal research protocols, ensuring full compliance with IACUC regulations for both USDA and non-USDA species.

Data Infrastructure

Unify and streamline your data management with our comprehensive data infrastructure services, ensuring your data is accessible, secure, and consistent. Integrate disparate data sources into a single platform to improve data integrity, governance, and facilitate smarter business decisions.

Hosting

Simplify your hosting experience with our reliable and scalable hosting services, offering robust security, seamless performance, and compliance. By trusting us with your digital infrastructure, you can focus on innovation and growth while we ensure your applications run optimally and securely.

Transformative Benefits
for Every Stakeholder

For Research Teams & Principal Investigators

For Research Teams & Principal Investigators

  • Create Protocols Efficiently: Dynamic forms guide you through all compliance requirements and automatically pre-fill information from previous submissions.
  • Track Protocol Status in Real Time: Check the status of your protocols instantly without waiting for email updates.
  • Ensure Complete Protocols Before Submission: The system automatically checks for missing information and notifies you, reducing the need for back-and-forth communication and saving time.

For Regulatory Affairs & Compliance Officers

For Regulatory Affairs & Compliance Officers

  • Generate IND-Ready Documentation: Automatically compile FDA-compliant documentation from integrated protocol data.
  • Monitor CRO Studies Effectively:
    Track outsourced research with complete visibility into compliance status, progress, and data quality.
  • Maintain Continuous Audit Readiness: Document every decision, amendment, and communication automatically to ensure inspection-ready audit trails.

For Executive Leadership & Investors

For Executive Leadership & Investors

  • Increase Financial Transparency: Access real-time information on research spending, milestone progress, and ROI metrics.
  • Leverage Predictive Insights: Utilize AI/ML and data analytics to streamline your research compliance and administration workflows.
  • Support Strategic Decision-Making: Make informed choices on portfolio prioritization and resource allocation based on accurate, up-to-date data.

One Unified System.
Infinite Possibilities.

Unlike fragmented point solutions, Key Solutions provides a seamlessly integrated platform where different systems work together. Whereas AI and data analytics optimize everything in real-time so that you can manage multiple systems in one place and start experiencing true research operational excellence.

Implementation That Works for Biotech Teams

We understand that lean biotech teams cannot afford downtime, and every delay affects research timelines and regulatory submissions.

Phased Rollouts

The protocol application is created, submitted, and reviewed electronically, removing possibilities of data redundancy and human error.

Data Migration You Can Trust

We migrate all existing protocols, CRO study data, and historical records so your institutional knowledge remains intact and accessible.

Training Designed for Lean Teams

The protocol application is created, submitted, and reviewed electronically, removing possibilities of data redundancy and human error.

Fast Adoption, Minimal Disruption

Our implementation approach allows your team to continue research activities uninterrupted while quickly realizing the benefits of a centralized compliance platform.

Events

Explore our upcoming events and see what’s next in compliance and digital solutions.

Latest Insights

Discover fresh perspectives from global leaders with our collection of blogs on research compliance, administration, animal care, and more.

Discover What Our Integrated Solutions Can Do For Your Organization

Get in touch with us today, and one of our experts will connect with you shortly.