01 · Services

Clinical Development

From strategy to study success.

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At CORONIS Research, we bring science, precision, and commitment together to deliver clinical development solutions. From early human studies to post-marketing research, our full-service CRO supports your product’s lifecycle with efficiency, regulatory confidence, and uncompromising quality.

How a study runs

Design to closure, one coordinated file

01
Study design
- Concept and protocol
- Regulatory strategy
- Sample size and randomisation
02
Start-up
- Site selection
- RA and EC approvals
- CTIS and site activation
03
Execution
- Monitoring and site management
- IMP and logistics
- Recruitment and retention
04
Data
- Entry, queries and coding
- SAS / SPSS analysis
- Integrated statistical reports
05
Closure
- Database lock
- Clinical study report
- Archiving and publications

Therapeutic expertise

Where the work concentrates

28%
Oncology
14%
Haematology
8%
Rare diseases
8%
CNS
7%
Paediatrics

Protocol

Capabilities

Clinical research

01Phase I clinical trials (FIH, SAD, MAD, PK/PD)
02Phase II clinical trials
03Phase III clinical trials
04Phase IV clinical trials
05Real world evidence (RWE)
06Registries
07Observational studies
08PASS
09PAES
10Patient reported outcomes (PROs)
11Pharmacoeconomic studies

Study design & planning

01Concept development
02Protocol design
03Feasibility assessment
04Recruitment strategy

Clinical operations

01Feasibility & site identification
02Study start-up management
03Clinical trial submissions (CTIS & national)
04Investigator meetings
05Clinical monitoring (incl. RBM)
06Site management
07Site support services
08Records management
09IMP management

Data management & biometrics

01Data management plans
02Database design & validation
03Data cleaning & query management
04Medical coding & safety reconciliation
05Sample size calculation
06Randomization
07Statistical analysis plan
08Statistical analysis & reporting

Medical & scientific support

01Medical writing
02Publication planning
03DMC / DSMB coordination
04Safety surveillance & reporting
05Medical information
06KOL management

Quality GCP compliance

01Study quality oversight
02Inspection readiness

Project management

01Project planning & oversight
02Risk management
03Vendor coordination

Briefing

Full service overview

Download the PDF for capabilities and process, or write to us about a study.

More information (PDF)

Talk to us

Contact

Design to closure, one coordinated file

Study design

Concept and protocol
Regulatory strategy
Sample size and randomisation

Start-up

Site selection
RA and EC approvals
CTIS and site activation

Execution

Monitoring and site management
IMP and logistics
Recruitment and retention

Data

Entry, queries and coding
SAS / SPSS analysis
Integrated statistical reports

Closure

Database lock
Clinical study report
Archiving and publications