Clinical Research

Clinical Project Management

Our Project Management team ensure your clinical investigations stay on track, on time, and within budget. From project initiation to completion, our project managers handle timelines, resources, and communication across teams, ensuring the highest efficiency.

Study Design, Protocol Development and Medical Writing

At Iberania, we collaborate with Key Opinion Leaders (KOLs) in the design of clinical studies to create optimal and scientifically sound study protocols in compliance with ISO 14155. Whether you are planning early-phase trials or post-market studies, we ensure the design is adapted to your needs. Our services also include full clinical trial documentation development: 

• Clinical Investigation Plan - Protocol

• Investigator Brochure

• Informed Consent Form

• Monitoring Plan

• Annual Progress Report

• Clinical Investigation Report - Final Study Report

Safety

Safety  team ensures that adverse events and device deficiencies are promptly reported in compliance with regulatory guidelines. We manage the entire vigilance process, from subject data collection to reporting. Iberania also offers the development of safety update reports and safety subject narratives.

Site Selection, Management and Monitoring

Iberania guarantees the selection of experienced hospitals and sites that meet the requirements of the study by using our established network. We ensure the proper qualification, initiation, management, monitoring, and close-out of all investigational sites.

We also provide paralegal support in the clinical trial agreement negotiation.

Iberania performs the monitoring of the data according to the monitoring plan, ensuring compliance and accuracy throughout the study until closure.

These services includes the conduct of Site Qualification Visits (SQV), Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and Close-Out Visits (COV).

Ethics Committee and Competent Authority Submission

Navigating regulatory and ethical requirements can be challenging. Our team specializes in Ethics Committee and Competent Authority Submission, ensure your clinical investigation is in full compliance with local and international guidelines and laws. From initial submissions to approvals, we manage the entire process, ensuring timely responses and efficient handling of all regulatory documentation. We work closely with local authorities to minimize delays.

Publication and Committee Management

The Publication and Committee Management services include the coordination and support of the study committees throughout the entire process, from assembling the right experts to managing committee relationships.

We assist in identifying and recruiting committee members, handling the negotiation of agreements, organizing and coordinating meetings, developing meeting reports, and maintaining regular follow-up to ensure timely decisions and deliverables. Some examples of committees we manage include:

• DSMB (Data Safety Monitoring Boards)

• CEC (Clinical Events Committee)

• Steering Committee

• Publication Committee

Data Management and Biostatistical Analysis

The Data Management and Biostatistical Analysis services include high-quality data collection, cleaning, validation, and analysis. We manage data throughout the entire study, ensuring its accuracy, integrity, quality, and reliability.

These services also include:

• Data Management Plan

• Statistical Analysis Plan

• Case Report Forms

• Electronic Data Capture design and programming

• Sample size calculation

• Biostatistical Analysis

• Validation of Tables, Listing, and Figures (TLFs)