Clinical Trial Application (CTA) Guide for Biopharma and Medtech Teams

Launching a clinical trial outside the United States requires more than a strong protocol. It requires regulatory approval in the form of a Clinical Trial Application (CTA).

For many life sciences teams, especially those preparing their first global study, the CTA can feel like a maze of regional requirements, submission portals, and documentation standards.

Unlike the FDA’s IND process, CTAs are reviewed by both regulatory authorities and ethics committees, which adds complexity to planning and timelines. A well-prepared CTA not only secures trial approval, it also signals to regulators that your organization is equipped to manage compliance throughout the study.

In this post, we’ll walk through what a CTA is, what it must include, how the process varies across regions, and how the right systems can reduce risk and speed time to submission.

What is a CTA?

A Clinical Trial Application (CTA) is the formal request submitted to regulatory authorities to gain approval for conducting a clinical trial in humans outside the United States. It serves a similar role to the Investigational New Drug (IND) application in the U.S., but with important regional differences.

The CTA provides regulators and ethics committees with enough information to assess whether the proposed trial is scientifically sound and ethically acceptable. It includes details on the investigational product, the trial design, the qualifications of investigators, and the safeguards in place to protect participants.

For biopharma and medtech companies looking to expand globally, the CTA is a critical milestone. Without it, no clinical trial activity can begin.

Understanding what regulators expect in a CTA and how those expectations differ across jurisdictions is key to avoiding costly delays and ensuring your program stays on track.

Key Components of a CTA

A strong CTA is built on clear, well-organized documentation that gives regulators confidence in both your science and your processes.

While the exact requirements vary by region, most authorities expect the following elements:

• Administrative Forms and Cover Letters – Basic information about the sponsor, trial sites, and investigators, along with a signed statement of compliance.

• Clinical Protocol – The full trial plan, including objectives, study design, methodology, statistical considerations, and participant protections.

• Investigator’s Brochure (IB) – A comprehensive summary of preclinical and clinical data on the investigational product to date, ensuring investigators are equipped to evaluate risks and benefits.

• Quality and Manufacturing Information (CMC Section) – Details on how the investigational product is manufactured, characterized, and controlled, demonstrating consistency and safety.

• Ethics Committee Approvals – Confirmation that an independent ethics body has reviewed and approved the trial to safeguard participant welfare.

• Safety Data and Supporting Documentation – Nonclinical study reports, prior human trial data (if available), and other evidence to support that the trial is reasonably safe to conduct.

Sponsors often underestimate the effort required to assemble and harmonize these pieces, particularly when managing multiple versions across teams and geographies. Misalignment between documents is one of the most common reasons regulators issue requests for clarification, which can slow the entire approval process.

Differences Between A CTA vs IND

Many teams familiar with FDA requirements are surprised by how different the Clinical Trial Application process looks outside the U.S. While the CTA and  IND share the same goal — regulatory authorization to begin human trials — the path to approval is not identical.

• Regulatory Scope – An IND is submitted only to the FDA. A CTA, by contrast, often requires approval from both the national regulatory authority (such as EMA member states, Health Canada, or MHRA in the UK) and an independent ethics committee.

• Submission Portals – In the U.S., INDs are submitted directly to the FDA. In the EU, sponsors now submit through the Clinical Trials Information System (CTIS), which centralizes applications across member states, while other countries maintain their own national systems.

• Timelines – The FDA has a 30-day review period for INDs. CTA timelines vary widely: some countries commit to 30 days, others take longer depending on ethics review and the completeness of the application.

• Documentation Requirements – The core elements (protocol, investigator’s brochure, safety data) are similar, but CTAs often require more extensive administrative forms and evidence of local site and investigator readiness.

For companies running global trials, this divergence means careful coordination. A submission package tailored for the FDA won’t necessarily meet EU or Canadian standards. Harmonizing documentation early reduces rework, shortens timelines, and prevents inconsistencies that can create regulatory risk.

The CTA Submission Process

Preparing and submitting a CTA requires more than pulling documents together. Each step must be planned and sequenced carefully to keep your trial timeline on track.

1. Pre-Submission Activities

Most sponsors benefit from engaging with regulators before filing. Scientific advice meetings or consultations provide clarity on expectations for the investigational product, trial design, and documentation.

Addressing regulator questions early can prevent rejections or long delays later.

2. Submission Formats

In Europe, all CTAs are now submitted through the Clinical Trials Information System (CTIS), which harmonizes the process across EU member states. Other countries, such as the UK, Canada, and Japan, maintain their own national submission portals.

Some regulators still accept paper-based or mixed-format submissions, making it critical to confirm requirements in advance.

3. Timelines and Review

Regulators typically review CTAs in parallel with ethics committees. While some countries commit to a 30-day review period, timelines vary widely depending on the completeness of the submission and the efficiency of ethics review.

Missing or inconsistent documentation is one of the most common causes of delay.

Speaking of delays, the following pitfalls are the most common reason that life sciences teams experience delays during the CTA submission process.

• Submitting incomplete or inconsistent data across the protocol, IB, and CMC sections

• Overlooking country-specific administrative forms

• Mismanaging communications with multiple regulators and ethics bodies

• Underestimating the lead time required to coordinate across sites and geographies

Sponsors that invest in rigorous preparation and early regulator engagement see smoother reviews and faster approvals, helping trials begin on schedule.

Maintaining Compliance After CTA Approval

Securing CTA approval is a major milestone, but it is only the beginning of your regulatory obligations. Once a trial is underway, sponsors must maintain compliance with ongoing reporting and oversight requirements.

Substantial Amendments

Any significant change to the protocol, investigational product, or trial conduct must be submitted as a substantial amendment. Regulators and ethics committees review these updates to ensure participant safety and data integrity remain protected.

Safety Reporting

Sponsors are responsible for monitoring and promptly reporting adverse events. This includes Suspected Unexpected Serious Adverse Reactions (SUSARs), which must be reported within strict timelines. Failure to maintain robust pharmacovigilance processes can result in trial suspension or regulatory penalties.

Annual Progress Reports

Most jurisdictions require sponsors to provide yearly updates on enrollment, safety, and study progress. These reports demonstrate ongoing compliance and give regulators visibility into the trial’s trajectory.

Renewals and Extensions

In some regions, CTA approvals are time-limited and must be renewed if the trial extends beyond the original authorization period. Sponsors need reliable systems to track these timelines and ensure renewals are filed on time.

Maintaining compliance after CTA approval reinforces credibility with authorities and builds trust that your organization can manage trials responsibly, paving the way for smoother approvals in future studies.

How Kivo Supports CTA Submissions

Managing a CTA requires coordinating inputs from regulatory, clinical, quality, and manufacturing teams across multiple geographies.

For many organizations, the biggest risk is not the science itself but the complexity of documentation, version control, and communication.

This is where Kivo makes a difference.

One Source of Truth

Kivo eliminates silos by storing all regulatory, clinical, and quality documentation in a single, validated system.

• Kivo's RIM system is designed for the modern regulatory needs of pharma, medical device, biotech, and combination product teams, with a focus on usability.
• Kivo's QMS is designed for the modern quality needs of pharma, medical device, biotech, and combination product teams, with a focus on affordability.
• Kivo's eTMF system is designed for the modern clinical  needs of pharma, medical device, biotech, and combination product teams, with a focus on scalability.

Rather than being three separate systems stitched together after the fact, all three are built on the same underlying document management system. This means files never need to be duplicated, reconciled, or revalidated.

All teams work from the same document and the same version, with full visibility.

Streamlined Collaboration

Whether you’re preparing the clinical protocol, updating the investigator’s brochure, or compiling country-specific forms, Kivo makes it simple to coordinate across internal stakeholders and external partners. Role-based permissions ensure the right people have access at the right time.

Audit-Ready Documentation

Every edit and approval is tracked automatically, giving regulators a clear view of your documentation history. This reduces the burden of preparing for audits and builds confidence in your compliance processes.

Proven Results

Biotechs and mid-sized pharmas have used Kivo to accelerate CTA preparation by cutting down on duplicate work, avoiding version conflicts, and reducing revalidation cycles. In practice, this means faster submissions and fewer regulatory delays.

With Kivo, your team can focus on the science and strategy behind your trial, while the system handles the complexity of compliance and documentation.

Conclusion

Submitting a CTA is one of the most important steps in taking your therapy global. It requires precision, coordination, and ongoing compliance across the entire life of the trial. For many teams, the process is slowed by fragmented systems, duplicate documents, and unclear responsibilities.

With the right approach and the right tools, CTA preparation doesn’t have to be a bottleneck.

Kivo helps life sciences companies streamline every stage of the process, from assembling initial documentation to maintaining compliance after approval. The result is faster submissions, fewer delays, and greater confidence in regulatory interactions.

If you’re preparing a CTA or expanding your clinical operations internationally, now is the time to explore how Kivo can help. Schedule a demo to see how we simplify CTA submissions and give your team the support it needs to move studies forward with confidence.