Clinical Studies

A dedicated service to assure quality and regulatory compliance

Clinical Compliance

Our services

Auditing
QMS Implementation
Root Cause Analysis & CAPA
Clinical Trial Risk Analysis
Training
Inspection readiness
Clinical Process Mapping
Clinical Assessment For Due Diligence
GcP Regulated Data & Records Integrity

Do you need help in the compliance with the regulatory Good Practices for your business?

We can offer a full range of tailored solutions for your business, covering your needs throughout the entire product’s life cycle.

Would you like to know more?

Clinical Research Operations

PQE Group can support your business with Clinical Research Services (CRO), as follows:

PQE Group has got you covered

Medical Device

Our experts know what it takes to achieve regulatory compliance of your MD or IVD.
Click on the button below to get started.

FemTech

Innovative tools, and technological advancement, both, in the public and the private sectors, are emerging to address women’s health and wellbeing.

Medical Cannabis

The Therapeutic Cannabis market is rich of possibilities, and it provides natural and innovative solutions, to a wide range of health related conditions.
Learn how we can support your business.

CRO Services in detail

Project Management

Project Management
Monitoring Plan
Risk Analysis Plan
Preparation/ finalization
Trial Master File (TMF) maintenance

Study Setup

eCRF maintenance & system/study specific validation
Site identification, selection and qualification
Site contract management
Site regulatory compliance – maintenance package

Submission to RA/EC

Clinical Trial Application to Regulatory Authorities (RA) and EC
RA/EC interactions/periodic activities
End of Study Notification to national RA/EC
Pre-clinical Q-Submission
Investigational Device Exemption (IDE) or Humanitarian Device Exemption (HDE) application
Significant risk or Non-significant risk determination
aIRB applications

Study Conduct and Monitoring

CRA/Team training
Site management
Management of IMP

Safety Management

Safety Management Plan preparation and execution
Assess requirement for expedited reporting to the Authorities
SUSAR submission to CE/ Investigators/Authority
Annual Safety Report /DSUR to Regulatory Authority/ EC

Data Management and Biometry

Data Management & Data Validation Plan development/ finalization
Data clean up and query management
Data coding
Edit check
Statistical Analysis Plan
TFL Programming

Medical Writing

Study protocol /Clinical investigation
Informed Consent Form
Investigator’s Brochure
Investigational Medicinal Product Dossier (IMPD)
Clinical Study Report

Quality Assurance/Audit

Audit of a Study Protocol / Protocol amendments
Vendor’s audit
Audit of the Trial Master File
Site audits
Audit of the Final Clinical Study

The voice of our experts

Hear from our experts’ on success and on regulatory compliance

«In the fields of advanced science, technology, and innovation, governments have to provide space for strategic partnerships, and set clear priorities. Additionally, it is crucial to take a human centered approach, when engaging in economy, studies or entrepreneurship».

Moshe Hod

Chief Medical Advisor

«Phase I-II trials are less profitable for the CRO’s, nonetheless High Quality Standards have to be maintained. This will allow businesses to reach the III-rd phase, with maximum efficiency. Without the need to waste time, and re-invest their capital.

The rights, safety, and well-being of the trial subjects should always be the priority. Hence, the Quality, Integrity and Reliability of the clinical trial, and of its results should be assured».

Marianna Esposito

GCP Compliance and ReSQ-UP Units Manager

So what is ReSQ-UP?

Our Compliance experts will answer to all your doubts in our dedicated series of video.

Ask us anything.

We have 20+ years of experience, nothing can really scare us.