Clinical trials designed to generate robust evidence
The clinical trials allow for a rigorous evaluation of the safety, efficacy, and behavior of medications, medical devices, procedures, or new therapeutic strategies. For their results to be solid, each study must be based on well-defined research and be conducted in accordance with a clear, reproducible methodology that conforms to scientific requirements y applicable regulatory.
In OMEDICS We offer specialized support in the design, planning, and development of clinical trials. Our team brings together clinical expertise, research methodology, statistical analysis, and medical writing to bring coherence to the project y facilitate the orderly progression of each phase, documented and oriented towards obtaining reliable results.
What does the service consist of
The service it adapts to the level of development of each project. We can intervene from the early stages, helping to transform a clinical idea into a viable research question, or join studies already underway that need methodological, statistical, and documentary support o Scientist.
We work on design definition, protocol development, statistical planning, variable organization, scientific documentation development, and data analysis and interpretation. The goal is for all the methodological decisions are justified and that there is consistency between the proposed hypothesis, the collected data and the conclusions reached.
Depending on the project needs, the service may include:
- Definition of the research question and study objectives.
- Review of the scientific and methodological feasibility of the project.
- Clinical trial design and definition of study groups.
- Preparation or review of the research protocol.
- Definition of primary and secondary variables.
- Sample size calculation and justification.
- Development of the statistical analysis plan.
- Design of the data collection forms.
- Support in the preparation of scientific and technical documentation.
- Statistical analysis and interpretation of results.
- Preparation of scientific reports and manuscripts.
Who is it intended for
Our service is aimed at professionals and organizations that need develop a clinical trial with a solid methodological basis, but which internally do not have all the necessary resources to tackle the design, analysis, or documentation of the project.
We work mainly with:
- Physicians and researchers who want to advance their own line of research.
- Hospitals, private clinics, and healthcare centers.
- Research groups and clinical units.
- Laboratories and pharmaceutical companies.
- Medical device and health technology companies.
- Scientific societies and foundations.
- Academic institutions and graduate programs.
- Promoters who need specialized methodological or statistical support.
- Teams that wish to review or reinforce an already developed protocol.
- Researchers who need to analyze and publish the results of a trial.
Benefits and expected results
One clinical trial it does not depend solely on having a good idea. It also requires proper planning, a precise definition of the variables, and an established analysis strategy before data collection begins.
The accompaniment of a specialized team it allows anticipating potential difficulties, improving the quality of the information obtained, and reducing the risk of methodological limitations arising that could compromise the interpretation of the results.
Among the main benefits are:
- Solid methodological design: Adapted to the objectives, population, and specific characteristics of the study.
- Greater scientific coherence: Between the hypothesis, the variables, data collection, and statistical analysis.
- Reduction of errors and biases: Through the early identification of limitations and confounding factors.
- Efficient planning: With clearly defined phases, deadlines, and deliverables from the start.
- Reliable and interpretable results: Analyzed from a statistical and clinical perspective.
- Greater project traceability: With organized documentation and duly justified methodological decisions.
Workflow
Each clinical trial presents different needs. Therefore, we begin with an initial project review to understand its status, objectives, study population, the intervention to be evaluated, and available resources. Based on this information, we define the scope of the service, priority tasks, and the documents that must be developed.
The work is organized by clearly delimited phases, periodic reviews and concrete deliverables. This methodology allows the team to know at all times the project status, the pending decisions and what about next steps to be addressed.
Each clinical trial presents different needs. Therefore, we begin with an initial review of the project to understand its status, objectives, study population, the intervention to be evaluated, and available resources. Based on this information, we define the Scope of service, the priority tasks and the documents that must be developed.
The work is organized by clearly delineated phases, periodic reviews y tangible deliverables. This methodology allows the team to know the project status, pending decisions, and next steps to be addressed at all times.
The duration varies depending on the complexity, the number of centers, recruitment, and the planned follow-up. As a guideline, the initial design and document preparation phase is usually completed in a 6 to 12 weeks, while the full test can take longer than several months or years. Before starting, a schedule with clear phases, deadlines, and deliverables is defined.
- Initial feasibility report.
- General project schedule.
- Complete trial protocol.
- Statistical analysis plan.
- Data collection notebook.
- Results report.
- Final document for publication or dissemination.
- Definition of the idea and objectives.
- Evaluation of trial feasibility.
- Methodological design of the study.
- Preparation and review of the protocol.
- Ethical and regulatory preparation.
- Data collection and tracking.
- Analysis and communication of results.
Frequently Asked Questions
Can you help if we still only have a research idea?
Yes. We can intervene from the initial phase to analyze the feasibility of the proposal, formulate the research question, and define the most appropriate design. It is not necessary to have a complete protocol in advance.
Is it possible to hire only a part of the service?
Yes. The scope adapts to the team's needs. We can handle the project comprehensively or intervene only in specific tasks, such as methodological design, sample size calculation, statistical analysis, protocol review, or the preparation of the final report.
How long does it take to prepare a clinical trial?
It depends on the complexity and initial state of the project. Methodological and document preparation usually takes between 6 and 12 weeks, although timelines may vary depending on the number of revisions, the availability of information, and the characteristics of the study.
Does OMEDICS also perform statistical analysis?
Yes. We can develop the analysis plan before starting the study, review the quality of the database, and subsequently perform the statistical analyses. The results are presented along with a clear interpretation linked to the clinical objectives of the trial.
Can you help publish the trial results?
Yes. Once the study is completed, we can transform the results into a scientific report, a manuscript for a journal, a conference communication, or a presentation. We can also assist with journal selection and adapting the text to its editorial guidelines.
Contact us
If you have any questions or would like to tell us about your situation so we can determine which service best meets your needs, please contact us.
Call us
Should we talk on WhatsApp?
omedics@omedics.org
1 Navellos Street, Door 1, 46004 Valencia