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.

Full support to investigators

If you have a good research idea, we help you to bring up it to the reality

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