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.
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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

Foto Moshe Hod

«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
Foto Marianna Esposito

«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.

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