CRO Solutions

msCRO provides professional CRO solutions across the critical stages of research — from the design of clinical studies to data management, from biostatistical analysis to scientific reporting and publication preparation.

Each study is structured by evaluating the research question, hypothesis, target population, endpoints, data structure, analysis strategy, ethical requirements and publication goal together. The aim is not merely to run clinical research operationally, but to transform it into a methodologically defensible, statistically sound and scientifically strong research structure.

msCRO provides scientific support tailored to each study's needs for academic clinical studies, retrospective and prospective research, clinical drug and device studies, cosmetic product research, medical product evaluations and health-technology projects.

A · CRO

Research Design & Application File Support

The right research question, sound methodology and complete scientific file preparation form the foundation of strong clinical research.

01

Clinical Research Design & Methodology

Support for planning the research question, hypothesis, endpoints and an appropriate study design with scientific rationale. The clinical aim, data collectability, analysability and publication goal are evaluated together.

Research question and hypothesis framing
Defining primary / secondary endpoints
Study type selection
Randomized controlled, cohort, case-control and cross-sectional designs
Structuring inclusion / exclusion criteria
Scientific and statistical planning of variables
Methodological justification
Study design aligned with the publication goal

02

Ethics Committee & Institutional Application File Support

Support for preparing the study file scientifically, methodologically and statistically for ethics committee and relevant institutional application processes. The application file is structured coherently in terms of research aim, methodology, data collection, analysis plan and study documents.

Initial application file preparation support
Scientific structuring support for the research protocol
Preparation of ethics committee application documents
Statistical analysis plan for the application
Structuring the methods and sample sections
File integrity and consistency review
Scientific support for revision or supplementary documents

03

Study Documents (Protocol, Informed Consent and CRF)

Support for preparing the clinical research protocol, participant information/consent text and case report form drafts in alignment with the study design and analysis plan.

Study protocol draft
Informed consent / participant information draft support
Case report form design
CRF content planning
Variable list and data dictionary creation
Document revision and formatting support
Data collection form aligned with the analysis plan

B · CRO

Clinical Operations & Monitoring Support

Planning, coordination, monitoring documentation and orderly data flow are critical to the reliability of clinical research.

04

Clinical Project Management

Support for the management of clinical research through timeline planning, team coordination, process tracking and regular progress reporting.

Creating the study timeline
Defining milestones
Team and stakeholder coordination
Process and progress reports
Monitoring risk and delay areas
Tracking study documents throughout the process
Project flow aligned with publication and reporting goals

05

Monitoring (On-site & Remote)

On-site or remote monitoring of study sites supports protocol compliance, data integrity and regular tracking of study documents.

On-site monitoring support
Remote monitoring support
Creating a monitoring plan
Regular monitoring reports
Protocol compliance assessment
Data integrity and consistency checks
Reporting of monitoring findings

06

Clinical Data Management + CRF / eCRF Design

Data management support for collecting, organizing, checking and transforming clinical research data into an analysis-ready database.

CRF / eCRF design
Planning data variables
Data entry and validation support
Missing data checks
Outlier and inconsistency assessment
Data cleaning and quality control
Pre-database-lock controls
Building the analysis-ready data set

C · CRO

Biostatistics & Advanced Analytics

Scientific rigour is the goal at every step — from analysis planning to reporting, from classical statistical methods to research-oriented advanced analytic models.

07

Statistical Analysis Plan (SAP)

Support for preparing a statistical analysis plan suited to the study design, data structure and endpoints.

Defining the analysis strategy
Primary / secondary analysis methods
Determining statistical assumptions
Planning subgroup analyses
Sensitivity analyses
Defining the missing-data approach
Table and figure plan
Establishing the reporting format

08

Sample Size & Power Analysis

Sample size is calculated in line with the research hypothesis, expected effect size, variance assumptions, alpha level and the targeted statistical power.

Effect size assumptions
Variance and proportion assumptions
Power and alpha level selection
Sample size calculation
Sample planning by group ratios
Drop-out / loss-rate adjustment
Scenario and sensitivity analyses
Reporting for the application file or protocol

09

Statistical Analysis & Reporting (Tables, Figures and Clinical Study Report)

Conducting statistical analyses using SPSS, R and Python, with support for reporting results as tables, figures and clinical study reports.

Descriptive statistics
Group comparisons
Regression analyses
ROC and diagnostic performance analyses
Survival analyses
Multivariable modeling
Table and figure production
Clinical study report support
Scientific interpretation of analysis results

10

Advanced Analytics, AI & Radiomics (Research-Purpose Modeling Support)

Research-purpose methodological and statistical support for machine learning, radiomics feature extraction, predictive modeling and model validation processes.

Machine learning model development
Clinical predictive modeling
Risk scoring model development
Radiomics feature extraction
DICOM data preprocessing support
Post-segmentation radiomics analysis
Internal / external model validation
ROC / AUC analysis
Calibration and decision curve analysis
SHAP and model explainability
Academic reporting support

D · CRO

Medical Writing & Publication Process Support

Strong academic structuring and publication-process support that make research findings visible with scientific integrity.

11

Medical Writing (Manuscripts, Case Reports, Congress Abstracts)

Support for structuring scientific studies into SCI/SCI-E manuscripts, case reports, reviews, congress abstracts, posters and short reports.

SCI / SCI-E manuscript preparation
Thesis-to-article conversion
Case report writing
Review article structuring
Congress abstract and poster text
Letter to the editor
Short communication
Academic text structuring

12

Publication Process & Academic Revision Support

Scientific and strategic support for journal selection, submission preparation, reviewer revision and response letter processes.

Journal selection strategy
Manuscript submission file preparation
Formatting to journal requirements
Scientific evaluation of reviewer comments
Structuring the revision text
Response letter preparation
Post-rejection restructuring
Publication strategy consulting