Our Services
Medical Writing
We offer specialized writing services in medical texts and scientific writing.
Our team has extensive knowledge on biological sciences (medicine, biochemistry, biology, biotechnology), postgraduate training and a background in clinical research. It brings us a high capacity to produce excellent quality medical / scientific documents altogheter.
The service has been oriented towards the needs of the pharmaceutical industry and academic fields, enriching a successful path with clients from both backgrounds.
Our medical writing services are carried out according to the standards of Good Clinical Practice:
English-spanish translation of regulatory documents.
Revision and validation of regulatory documents.
Documents writing.
Each of these services can be requested for the following documents:
Investigator’s brochure.
Study protocol.
Informed consent.
Progress / Final report.
Amendments.
In addition, our academic writing proposal includes:
- WRITING OF SCIENTIFIC ARTICLES
Reviews
Systematic reviews
Research article
Case reports
Case series
Clinical trials - CONFERENCE RESOURCES PREPARATION
Posters
Abstracts
Extended abstracts
Conferences
Quality Management
Writing of documents in accordance to ISO 9001 standard of quality.
Quality handbook:
- Standard operating procedures.
- Scope of the quality management system (clause 4.3).
- Documented information necessary to support the operation of the processes (clause 4.4).
- Quality policy (clause 5).
- Quality objectives (clause 6.2).
- Documented information required as necessary (clause 7.5).
- Records.
I+D
Experimental design
Over more than 10 years of clinical research experience support us, with generic and technical skills for assistance in experimental design.
Sample size estimation:
Prediction of the sample size in order to obtain significant results and optimization of the number of patients to recruit and human and financial resources involved in a clinical trial.
Experimental design by DOE analysis:
Design of an efficient way for the improvement of a process or product, with a minimum of experiments.
The following stages are included in the service:
- Factor screening test
- Optimization through design of few factors and several levels: response surface study.
- Multivariate analysis of multiple levels.
- Analysis of the significance of the factors.
Research project
Our team has professional training in clinical and basic research as well as extensive experience in clinical medicine and diverse specialties, which are useful for the preparation of documents of research proposals.
Design and comprehensive writing of the research project (preclinical and clinical trials), for different purposes such as grant requests or ethics committee forms:
- Development of the theoretical framework and literature search.
- General and specific objectives of the study.
- Selection of study variables and study design.
- Inclusion and exclusion criteria.
- Preparation of methodology according to available resources.
- Budget.
- Preparation of the research schedule (Gantt chart).
- References.
Data analysis
Collection, processing, and statistical analysis of data are included in our service:
- Descriptive analysis.
- Normality test: Shapiro-Wilk test, Bartlett test.
Mean comparisons:
Between 2 groups: Student’s t test or Mann- Whitney U test.
Between 3 or more groups: Analysis of variance (ANOVA) using Tukey or Kruskall- Wallis. Multiple comparisons test (Mann-Whitney test, Wilcoxon test)
Association studies between qualitative variables:
Chi square test, Fisher test (Odds ratio calculation, positive and negative predictive value).
Correlation studies between 2 quantitative variables:
Pearson’s correlation, Spearman’s correlation.
ROC analysis (Receiver Operating Characteristic)
Multivariate analysis:
Analysis of various factors contribution to an event or result, by implementation of multivariate analysis algorithms.
Dimensionality reduction using principal component analysis (PCA): exploratory data analysis and predictive model construction.
All our services can be presented in English or Spanish as requested.