msCRO — Medical Statistic CRO
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msCRO 18 YEARS
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Research Design & Ethics Committee Support

Professional support for research methodology, study design, protocol development and ethics committee submission processes in accordance with international scientific standards.

Successful scientific research begins with a robust study design. Clearly defining the research question, developing testable hypotheses, selecting an appropriate study methodology, identifying meaningful endpoints and establishing an ethically sound research framework are fundamental to producing high-quality scientific evidence.

msCRO provides comprehensive methodological support for researchers, universities, research institutions, healthcare organizations and the life sciences industry throughout the research design and ethics committee submission process. Our services include research methodology development, study design planning, protocol development, Statistical Analysis Plan (SAP) preparation, sample size and power calculations, endpoint definition, CRF/eCRF planning and scientific structuring of ethics committee submission documents.

Our expertise includes research question development, hypothesis generation, study design selection, randomized controlled trials (RCTs), observational studies, cohort studies, case-control studies, cross-sectional studies, diagnostic accuracy studies, real-world data (RWD/RWE) research, protocol development, Statistical Analysis Plans (SAP), sample size estimation, CRF/eCRF design, data collection planning, ethics committee documentation and regulatory research documentation.

Research planning is performed in accordance with internationally recognized standards including SPIRIT, CONSORT, STROBE, PRISMA, STARD, TRIPOD, CARE, RECORD, ARRIVE, CHEERS, ICH-GCP and the EQUATOR Network reporting guidelines. Methodological planning, data collection strategies, analytical frameworks and reporting requirements are integrated according to the specific characteristics of each research project.

Deliverables include research protocols, study methodology reports, Statistical Analysis Plans (SAP), sample size reports, CRF/eCRF designs, ethics committee submission documents, study flow diagrams, data collection plans and technical research documentation prepared in accordance with international scientific standards.

Sub-services

Hypothesis Development
Research Question Formulation
Primary / Secondary Endpoint Definition
Study Design Planning
Methodology Structuring
Ethics Committee Application File Support
Informed Consent / Participant Information Draft Support

Other services

01

Biostatistics & Data Analysis

International-standard biostatistics, advanced data analytics, machine learning and scientific reporting solutions for clinical and academic research.

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02

Clinical Research & CRO Solutions

Integrated CRO solutions for clinical research, including study planning, data management, biostatistics, medical writing and scientific reporting in accordance with international standards.

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03

Academic Publication & Medical Writing

Professional publication development, medical writing, editorial support and international publication management services for researchers, academic institutions, healthcare organizations and the life sciences industry.

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04

Publication Process & Peer Review Support

Professional support throughout the scientific publication process, from journal selection to manuscript acceptance, including publication strategy, editorial management and peer review support.

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05

Scientific Congress, Abstract & Presentation Services

Development of scientific research into congress abstracts, oral presentations, poster presentations and scientific communication materials aligned with international standards.

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06

Artificial Intelligence, Machine Learning & Radiomics

Machine learning, predictive modeling, radiomic feature extraction, model validation and explainable artificial intelligence solutions for clinical, academic and imaging data.

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