CRO Solutions

Methodological, statistical and scientific support across every stage of clinical research — from design to publication.

Integrated CRO Solutions for Clinical Research

msCRO provides integrated Clinical Research Organization (CRO) solutions across multiple stages of the clinical research lifecycle, from study planning to scientific reporting. Our multidisciplinary approach combines research methodology, clinical operations, data management, biostatistics, advanced analytics, medical writing and publication development to support high-quality scientific research.

The scientific quality of a clinical study depends not only on statistical analysis, but also on robust study design, protocol development, structured data collection, statistical planning, quality control, regulatory documentation and scientific reporting. Therefore, every project is developed by jointly evaluating its clinical objectives, methodological requirements, data structure, operational processes and intended scientific outcomes.

msCRO delivers scalable CRO solutions for pharmaceutical and biotechnology companies, medical device manufacturers, CROs, research institutions, universities, healthcare organizations and investigators, adapting each project to its scientific and operational requirements.

Our expertise includes:

Clinical study design and research methodology
Ethics committee and regulatory submissions
Clinical research documentation
Clinical project management
Clinical trial monitoring
Clinical data management
CRF / eCRF development
Statistical Analysis Plans (SAP)
Sample size determination and power analysis
Biostatistics
Advanced data analytics
Artificial intelligence and machine learning
Radiomics
Medical writing
Publication development
Clinical study reporting
Publication management
Peer review support

Projects are developed with reference to internationally recognized frameworks, including ICH-GCP, ICH E9, CONSORT, SPIRIT, STROBE, PRISMA, TRIPOD, STARD, CARE, RECORD, CDISC, SDTM, ADaM, ICMJE Recommendations and Good Publication Practice (GPP), according to the scope and requirements of each study.

Throughout the research lifecycle, methodological integrity, data quality, statistical reliability, scientific consistency and international reporting standards are integrated to support reliable and high-quality research outcomes.

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.

Clinical Research Design & Methodology

Structuring the clinical research question, hypotheses, target population, study endpoints and study design according to scientific, statistical and operational requirements.

Research Question & Hypothesis Development
Definition of Clinical Objectives & Research Aims
Target Population Definition
Primary & Secondary Endpoint Development
Study Design Selection
Randomized Controlled Trial Design
Cohort, Case-Control & Cross-Sectional Study Design
Prospective & Retrospective Research Planning
Observational & Real-World Data Studies
Diagnostic Accuracy & Prognostic Study Design
Eligibility Criteria Development
Control & Comparator Group Planning
Variable & Data Structure Definition
Assessment of Bias, Confounding & Effect Modification
Statistical Analysis Strategy Planning
Sample Size & Feasibility Assessment
Data Collection Schedule & Study Flow Planning
Alignment with International Research Standards

Ethics Committee & Regulatory Submission Support

Integrated development of research protocols, scientific rationale, methodology, statistical planning, data collection documents and submission files for ethics committee and regulatory applications.

Ethics Committee Submission Strategy
Initial Submission Package Preparation
Scientific Structuring of the Study Protocol
Scientific Rationale & Research Objective Development
Definition of Primary & Secondary Endpoints
Methodology & Study Design Development
Statistical Analysis Plan (SAP)
Sample Size & Power Analysis
Eligibility Criteria Development
Data Collection Plan & Study Workflow
Case Report Form (CRF / eCRF) Planning
Informed Consent Forms & Participant Information
Data Protection & Confidentiality Documentation
Ethics Committee Revision & Additional Document Support
Institutional & Regulatory Submission Documentation
Submission Package Consistency & Quality Review

Clinical Research Documentation: Protocol, Informed Consent & CRF/eCRF

Development of clinical study protocols, informed consent forms, participant information documents and CRF/eCRF documentation aligned with the study design, data flow and statistical analysis plan.

Clinical Study Protocol Development
Protocol Synopsis & Study Flow Development
Informed Consent Form
Participant Information Sheet
CRF / eCRF Design
CRF Completion Guidelines
Variable List & Data Dictionary
Schedule of Assessments
Data Collection Forms
Source Documentation & Data Flow Planning
Integration of Study Endpoints into Documentation
Alignment with the Statistical Analysis Plan
Cross-Document Consistency Review
Protocol Amendment Documentation
Document Revision & Version Control
Ethics Committee & Regulatory Submission Formats

B · CRO

Clinical Operations & Monitoring Support

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

Clinical Project Management

Professional planning, coordination, operational oversight, timeline management, risk assessment and project execution support for clinical research in accordance with international standards.

Clinical Project Planning
Study Start-up Planning
Project Timeline Management
Milestone Planning
Project Coordination
Research Team Coordination
Stakeholder Communication
Operational Oversight
Risk Assessment & Mitigation
Project Performance Indicators (KPIs)
Progress & Status Reporting
Project Documentation Management
Quality Process Monitoring
Study Close-out Planning

Clinical Trial Monitoring: On-Site & Remote Monitoring

On-site and remote monitoring of clinical research sites to systematically evaluate protocol compliance, participant safety, data quality, document integrity and study conduct.

Monitoring Strategy & Monitoring Plan
On-Site Monitoring Visits
Remote Monitoring
Risk-Based Monitoring
Site Initiation Visits
Routine Monitoring Visits
Site Close-Out Visits
Protocol Compliance Assessment
Participant Safety & Rights Oversight
Source Data Review
Source Data Verification
CRF / eCRF Consistency Review
Investigator Site File Review
Essential Document Review
Informed Consent Process Review
Data Query & Open Issue Follow-up
Protocol Deviation Assessment
Site Performance & Recruitment Monitoring
Corrective & Preventive Action Follow-up
Monitoring Reports & Follow-up Letters

Clinical Data Management & CRF/eCRF Solutions

Standardized collection, validation, cleaning, quality control and transformation of clinical research data into analysis-ready databases.

Clinical Data Management Plan
CRF / eCRF Design
Clinical Database Design & Configuration
Variable List & Data Dictionary
Schedule of Assessments
Data Entry Rules & Coding Standards
Data Validation Rules
Edit Checks & Automated Controls
Data Cleaning & Quality Control
Missing Data & Consistency Review
Data Query Management
Coding & Classification Processes
MedDRA & WHO Drug Coding
Laboratory Data & Reference Ranges
External Data Integration
Safety Data Reconciliation
Protocol Deviation & Data Compliance Review
Database Close-out Preparation
Pre-Lock Quality Control
Analysis-Ready Dataset Development
Data Transfer Specifications
Clinical Data Management Reporting

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.

Statistical Analysis Plan (SAP)

Prospective specification of statistical methods aligned with the study design, research hypotheses, endpoints and data structure before analysis begins.

Statistical Analysis Strategy Development
Analysis Population Definitions
Primary & Secondary Endpoint Analyses
Descriptive Statistics Planning
Primary & Secondary Hypothesis Testing
Statistical Model Specification
Covariate & Confounder Planning
Subgroup Analysis Definition
Interaction Analysis Planning
Repeated Measures & Longitudinal Analyses
Survival Analysis Planning
Missing Data Strategy
Outlier & Data Inconsistency Management
Multiplicity & Type I Error Control
Sensitivity Analyses
Interim & Final Analysis Planning
Analytical Handling of Protocol Deviations
Sample Size & Power Assumptions
Statistical Software & Programming Standards
Table, Figure & Listing Specifications
Quality Control & Analysis Validation Plan
SAP Revision & Version Control

Sample Size Determination & Power Analysis

Scientifically justified sample size determination and statistical power analysis based on study design, hypotheses, endpoints, expected effect size and analytical assumptions.

Research Hypothesis Definition
Primary & Secondary Endpoints
Effect Size Estimation
Variance & Event Rate Assumptions
Statistical Power Analysis
Alpha & Beta Error Planning
Superiority, Equivalence & Non-Inferiority Designs
Single-Arm & Multi-Arm Studies
Repeated Measures Studies
Sample Size for Survival Analysis
Diagnostic Accuracy Studies
Sample Size for Regression Models
Machine Learning Sample Size Estimation
Pilot Study Planning
Dropout & Attrition Adjustments
Interim Analysis Considerations
Adaptive Study Designs
G*Power, PASS & Simulation-Based Calculations

Statistical Analysis & Scientific Reporting

Statistical analysis for clinical and academic research, with results structured as tables, figures, statistical reports and clinical study reports.

Descriptive Statistics
Group Comparisons
Regression Analyses
Multivariable Modeling
Repeated Measures & Longitudinal Analyses
Survival Analyses
ROC & Diagnostic Performance Analyses
Correlation & Agreement Analyses
Outlier & Distribution Assessment
Missing Data Analyses
Sensitivity Analyses
Subgroup & Interaction Analyses
Propensity Score Methods
Mixed-Effects Models
Generalized Linear Models
Negative Binomial & Poisson Models
Firth Regression
Statistical Tables & Figures
Statistical Section of Clinical Study Reports
Publication-Ready Statistical Reporting
Additional Analyses for Peer Review

Advanced Analytics, Artificial Intelligence & Radiomics Solutions

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

Machine Learning Model Development
Clinical Predictive Modeling
Risk Score & Prognostic Model Development
Classification & Regression Models
AI-Driven Data Analytics
Feature Engineering & Variable Selection
Dimensionality Reduction
Class Imbalance Management
Model Optimization & Hyperparameter Tuning
Internal & External Validation
Cross-Validation & Bootstrap Validation
ROC, AUC & Performance Analysis
Calibration Analysis
Decision Curve Analysis
Explainable Artificial Intelligence & SHAP
Radiomic Feature Extraction
DICOM Data Preprocessing
Post-Segmentation Radiomics Analysis
Clinical & Radiomic Data Integration
Radiomic Signature Development
Nomograms & Risk Prediction Tools
Model Comparison & Performance Reporting
Scientific Visualization & Technical Reporting

D · CRO

Medical Writing & Publication Process Support

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

Medical Writing & Publication Development

Medical writing, publication development, editorial planning and scientific documentation solutions for clinical research and life sciences projects in accordance with international publication standards.

Publication Strategy Development
Medical Writing
Publication Development
Original Research Articles
Publication Development from Thesis Data
Systematic Reviews
Meta-analysis
Network Meta-analysis
Case Reports
Case Series
Short Communications
Book Chapters
Conference Abstracts
Poster Presentations
Graphical Abstracts
Clinical Study Reports (CSR)
Clinical Evaluation Reports (CER)
Investigator Brochures (IB)
Regulatory Writing
Cover Letters
Responses to Reviewers
Journal Formatting
Submission Packages

Publication Management & Peer Review Support

Professional management of journal selection, manuscript submission, editorial assessment, peer review, revision and resubmission processes in accordance with international publishing standards.

Publication Strategy Development
Target Journal Evaluation
Journal Selection
Technical Pre-submission Review
Journal Formatting
Submission Package Preparation
Cover Letter Development
Responses to Reviewers
Peer Review Management
Editorial Communication
Resubmission Support
Publication Tracking
Editorial Quality Control
Publication Process Coordination

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