Clinical Research Services

Streamline drug development with ReSQ-UP’s tailor-made CRO services, encompassing everything from clinical compliance to operational efficiency.

PQE Clinical Research Services Industries

Contract Research Organization Services

With PQE Group’s world-class Clinical Research Services, count on our support for expert-led observational studies, pre/post-marketing investigations, and more.

Quality-driven CRO Backed by 25+ Years of Experience

ResQ-UP utilizes PQE’s 25+ years of industry experience to provide customized, high-quality clinical research solutions, from site selection to regulatory approval, all within your budget and timeframe.

PQE Clinical Research Services Global Coverage
Global Reach

Tap into ReSQ-Up’s global network powered by PQE Group’s 45+ offices around the world.

PQE Clinical Research Services Tailor made
Tailor-Made Solutions

ResQ-UP’s solutions are tailor-designed to your unique needs and calibrated to complement your project requirements to guarantee optimal results. 

PQE Clinical Research Services Strategical Positioning
Strategically Positioned

Our strategic position in various sectors including Medical Devices, FemTech, and Medical Cannabis plus our top-notch expertise and extensive clinical trial center network means you can count on us to help you meet your goals.

PQE Clinical Research Services Fast Responsiveness
Swift and Responsive

ReSQ-UP guarantees swift responsiveness to client needs, maintaining adherence to pre-agreed timelines and cost containment strategies thanks to PQE’s extnsive global network. 

PQE Clinical Research Services A Trusted Company
Reliable Expertise

ResQ-UP leverages PQE’s 25+ years in Life Sciences, with professionals boasting diverse backgrounds to guarantee local and international expertise in clinical trial quality management.

Quality CRO Services Tailored To Your Needs

Medical Writing

Elaboration of the following documents: 

  • Clinical Study Protocol / Clinical investigation Protocol 
  • Informed Consent Form / GP Letter 
  • Investigator’s Brochure 
  • Investigational Medicinal Product Dossier (IMPD) 
  • Clinical Study Report – Clinical Investigation Report  

Regulatory Intelligence and Submission

  • Country/Site Feasibilities 
  • Clinical Trial Application to Regulatory Authorities and EC (CTIS Submissions) 
  • Interim + 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 
  • Contract Negotiation 

Project Management and Monitoring

  • Elaboration of the following documents: 
  • Project Management Plan  
  • Monitoring Plan  
  • Risk Analysis Plan 
  • Management of the following aspects
    • Monitoring Team Selection & Training  
    • Trial Master File (TMF/eTMF) maintenance 
    • Site Management
      • Initiation Visits
      • Interim Visits
      • Remote Monitoring
      • Close Out Visits
  • IMP Management

Documentation Management

Elaboration of the following tools: 

  • Trial Master Files Pape (TMF) or electronic (eTMFs) 
  • Investigator Site File (ISFs) 

Electronic Case Report Form (eCRF)

  • EDC customized on Study requirements  
  • ePRO solutions  
  • IWRs  
  • eSAE 
  • IMP – Accountability Management  

Data Management & Statistics

Elaboration of the following documents: 

  • Data Management & Data Validation Plan development/ finalization 
  • Statistical Analysis Plan 

Management of the following aspects: 

  • Data clean up and Query management 
  • Data coding Edit-Check  
  • TFL Programming 
  • Statistical Analysis 

Safety Management (Pharmacovigilance)

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

Quality Assurance

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

Clinical Trials Services Designed for Compliance and Efficiency

Mitigate risks and ensure your trials are GCP compliant and quality-driven with ResQ-UP’s Clinical Trial Compliance Services.


GCP compliance auditing solutions conducted globally

Implementation of Quality Management Systems

Establishing robust frameworks and processes to guarantee consistent Quality for all client requirements

Root Cause Analysis and Corrective and Preventive Actions (CAPA)

Identifying underlying issues contributing to non-compliance and implementing strategies to address them effectively


Providing comprehensive and accurate educational programs

Clinical Trial Risk Analysis

Evaluating potential risks associated with clinical trials and developing strategies to mitigate them

Inspection Readiness

Ensuring readiness for regulatory inspections through meticulous preparation, documentation review, and adherence to GCP and protocol requirements

Clinical Process Mapping

Visualizing and optimizing clinical workflows to enhance efficiency and streamline operations

Clinical Assessment for Due Diligence

Conducting thorough assessments of clinical trial data integrity and compliance to facilitate informed decision-making for potential partnerships or acquisitions

Ensuring GCP Regulated Data & Record Integrity

Maintaining the accuracy, completeness, and reliability of clinical trial data and records in accordance with GCP guidelines to uphold data integrity and regulatory compliance

Count On Us For Clinical Trial Compliance

«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».

Foto Marianna Esposito

Marianna Esposito

GCP Compliance and ReSQ-UP Units Manager

Discover how ReSQ-UP can transform your clinical trials

Optimize every aspect of your clinical trials with ReSQ-UP and reach your goals on time without stretching your budget.