Pre-Study
During the pre-study phase, we share our expertise by working side-by-side with the researcher.
Advice on methodology and study design
Design of protocols, patient information leaflets, and informed consents
Design of case report forms (paper or electronic format)
Processing of EudraCT number applications and appropriate documentation
Design and preparation of the trial master file, investigator site file, and pharmacy file
Printing of study materials
Preparation of the clinical trial calendar
Regulatory affairs: preparation of documentation and submission to EC and national/regional regulatory authorities
Insurance policy management
Site contract negotiations
Clinical trial registration in www.clinicaltrials.gov
Study initiation visits
Legal and administrative advice
Site and investigator selection
Follow-up
The follow-up phase comprises a series of tasks that are essential for optimal performance of the study: monitoring and promoting recruitment, organizing meetings with researchers, monitoring visits, sample transport management and investigational product management.
Monitoring visits
Remote monitoring and site management
Detection and follow-up of protocol deviations
Organization of investigator meetings
Centralized randomization
Monitoring of recruitment
Investigational product management: stock control, monitoring of the expiration date…
Biological samples management
Amendments submission to EC and national/regional regulatory authorities
Queries: generation, monitoring, and resolution
Annual reports
Adverse events management
Closure
The relevant ethics committee and other bodies (e.g., Spanish Agency of Medicines and Medical Devices and Autonomous Communities) are notified of the completion of the study according to the legal requirements of each type of study. Close-out visits are scheduled, and the final report is written.
Close-out visits
End of study procedures
Final study report
Payment management
Data Management
The area of data management covers all those tasks that are necessary to support researchers in many varied aspects of a study. It also includes data validation and the generation and management of queries in order to ensure the validity of the data generated by the study.
Database creation and design
Data validation
Data entry
Generation and management of queries
Data management plan
Statistics Support
Biostatistics involves the application of statistical techniques in study design, data analysis, and resolution of problems. Our statisticians develop statistical and computational methods for clinical trials and observational studies. Our multidisciplinary collaboration with Universitat Politècnica de Catalunya, Barcelona Tech (UPC) enriches the quality of our work and enables students to participate in research. Our particular areas of expertise include longitudinal data analysis, missing data, survival, and pharmacoeconomics.
Preparation of the statistical analysis plan
Calculation of sample size
Preparation of randomization lists
Statistical analysis
Statistical reports
Statistical advice
Clinical Pharmacology
Recently we have incorporated a team of experts that can provide specific support in the area of Clinical Pharmacology. By using drug modeling and simulation methodology they will help you on the design and protocol elaboration when you need (1) the simplest clinical trial design (by applying optimal design strategies), (2) to find the most adequate design of drug-drug interaction studies, (3) help for a first-in-human drug administration, (4) to decide the best formulation to go for a bioequivalence study, (4) to perform a bioequivalence study according to the Regulatory standards, (5) to perform pharmacokinetic/pharmacodynamic (PK/PD) modeling and simulation; all together with a rapid and a high quality data analysis and interpretation of the results.
Phase I Clinical Trials
FLS-Research Support counts with appropriate logistics for conducting phase I clinical trials in different therapeutic areas.
Translation
Translation of protocols and other study documents.
Adaptation of international protocols to Spanish legislation.