Our Services
CLINICAL SERVICES
Design and execution of clinical studies with human and veterinary medicines, medical devices (MDR and IVDR), and dietary supplements.
Follow us
Preparation and Review of Documentation
- Sample size calculation and study design.
- Writing and review of the protocol, patient information sheet, and other study materials.
- Design of case report forms, data updates, and data extraction.
- Scientific advice with the regulatory agency.
Regulatory Procedures
- Management of authorizations with ethics committees and regulatory bodies (submission, follow-up of claims and amendments).
- Study registration (clinicaltrials.gov, ReEC, CTIS).
- Ongoing follow-up of regulatory procedures throughout the study.
Study Monitoring
- Development of the Monitoring Plan.
- Start-up, monitoring, and close-out visits.
- Data management and resolution of discrepancies or queries.
- Preparation and management of the investigator's file.
- Pharmacovigilance (adverse event reporting and medication tracking).
Project Management
- Project coordination (sponsor, investigators, and collaborating companies).
- Team follow-up (meetings and ongoing support throughout the study).
Statistical Analysis
- Development of the statistical analysis plan.
- Statistical analysis of data and creation of graphs and tables for publication.
Results Communication
- Preparation of the final results report.
- Support for researchers during the revision process.
Medical Devices
- Preparation of clinical evaluation report for MDR and IVDR.
- Preparation of periodic review reports (CER).
- Support in preparing clinical research applications with AEMPS (Spanish Agency for Medicines and Health Products):
Study protocol preparation.
Support in obtaining approval from the Ethics Committee.
Design, development, and preparation of the Investigator’s Brochure (IB).
Our Work Process
Discover the work process we follow at Konexio Biotech to shape your project in an integrated way.
Step-01
Study Protocol Design
We define a protocol tailored to the client’s needs and regulatory standards, ensuring clarity in objectives, study design, and operational procedures.
Step-02
Site Selection and Recruitment
We identify the most suitable research centers and develop effective patient recruitment strategies, optimizing time and resources.
Step-03
Clinical Trial Monitoring
We continuously monitor site activities to ensure protocols are followed, regulatory compliance is maintained, and high-quality data is collected.
Step-04
Clinical Data Management
We use electronic tools to collect, clean, and analyze clinical data, ensuring integrity and regulatory compliance.
Step-05
Study Report and Close-out
We prepare detailed final clinical reports and manage the administrative and operational closure of the trial, ready for regulatory authorities’ review.
Want to learn more about Clinical Services?
We cover all phases, from planning and designing preclinical and clinical studies to implementing and completing clinical trials in phases I-IV.
We use criteria based on the center's prior experience, access to the study population, available infrastructure, and compliance with international regulations.
We work closely with the sponsor, the research team at participating centers, and other collaborators involved in the study to develop effective strategies that ensure recruitment objectives are met.
Yes, we have been involved in studies related to gene therapies, cellular therapies, tissue engineering, and cutting-edge biotechnology products.
We provide electronic data management services, from setting up the eCRF to data cleaning and analysis using validated tools.
We collaborate with sponsors to design efficient and practical protocols, ensuring clinical feasibility and regulatory compliance.
We implement specific risk management plans, including ongoing assessments and mitigation measures, to ensure patient safety and data quality.
Yes, we offer training in regulations, protocol management, and the use of electronic systems for investigators and clinical staff.
We document and analyze all deviations, taking immediate corrective actions and preventing recurrence through training or process adjustments.
Monday - Friday: 9:00 - 19:00 h.
