Home
Brands & Services
CRO services
Data collection
Market Access & HEOR
Medicine acceptability
Patient Recruitment
Our Team
Key staff
History & values
Compliance
Resources
ClinSearch News
Testimonials
Publications
Careers
Privacy Policy
Contact

Connect with us

CRO Services

1 2 3

Clinical Study Management

Resources

Senior Clinical Operations Director
Regulatory Affairs Director
Data Protection Officer
Project Leaders
CRAs
Clinical Operations Assistants

Description

Modelled on best-in-class industry standards, the clinical operations department has traditionally been the backbone of the services we offer. Our trained multilingual monitors are continuously supported by the senior staff of the department to meet the objectives of excellent regulatory and clinical operations service. Our department leaders have been at ClinSearch for many years, ensuring a strong adherence to our quality policy and uninterrupted contact with clients over the course of multi-year projects.

At ClinSearh, monitoring is always managed by permanent staff members with appropriate CRA qualifications or training, and fluency in the languages of your selected site locations. Languages that are represented on the team include French, English, German, Dutch, Spanish, Italian, Danish, Swedish, Arabic, Indian, Polish, Romanian and Bulgarian. CRAs are selected according to your study requirements and trained on the specificities of your protocol and product.

Daily activities are overseen by experienced Project Leaders under the direction of the Clinical Operations Director.

All submissions activities are managed by the Head of Global Regulatory Affairs
.

Our solutions

Site Selection & Feasibility
Regulatory submissions
On-site & Remote monitoring
Safety reporting
Recruitment-efficient solutions
Site management
TEC support
Project management

Standards & Guidelines

ICH Good Clinical Practice
ISO 14155
Good Epidemiological Practice
EU GDPR

Day-to-day activity

Routine monitoring, Europe & Middle East
Regulatory submissions, Europe & Middle East
Project management

Statistics & Medical writing

Resources

Biostatistics Director
Epidemiology Advisor
Medical Advisor
Statisticians
Medical Writers

Description

This integrated department handles the strategic planning, data crunching, and medical communications projects. Our methodology experts combinetheir know-how on statistical methodology and their expertise in scientific communications to deliver protocols and SAPs, write study documents, study reports and publications, and produce statistical reports and custom data analyses.

The main function of this department: conceiving and managing the best strategy for your clinical evaluation.

Our solutions

Protocol development & Review
Study documents writing
Sample size calculation
Statistical analysis plan
Statistical reports
Publications writing
Lay summaries for clinical trials

Standards & Guidelines

ICH E9
ECoP
ICH E3
STROBE
CONSORT

Day-to-day activity

SAS programming
R programming
Data modeling
Medical writing

Safety Reporting

Resources

Senior Clinical Operations Director
Safety Physician
PharmD Safety Specialist
QARA Manager
MedDRA coders

Description

ClinSearch employs a MedDRA-certified safety physician and a PharmD safety specialist focusing on the handling and reconciliation of ADRs and SAEs, signal & incident management, and support with risk management and minimization plans. The ClinSearch team has expertise with training investigators and supporting staff, medical review of CRFs, and the writing of safety reports.

We are also able to recruit key opinion leaders for Clinical Event Committees (CEC) & Drug Safety Monitoring Boards (DSMB). ClinSearch staff can write the manuals, manage the meetings and ensure the abjudication of endpoints. It is possible to collect the abjudication results online from any part of the world through an extension of EDClin.

The department can develop customized SOPs and tools for safety reporting and management.

Our solutions

Risk management plan
Study staff training
Handling of Adverse Drug Reactions
Handling of Serious Adverse Events
Reporting to CA & EC
CEC & DSMB management
Medical review
MedDRA coding
Case & Periodic safety reports
Quality control

Standards & Guidelines

Eudravigilance
MEDDEV
MedDRA

Day-to-day activity

AEs & SAEs reporting
MedDRA coding
Safety reports

1 2 3