Clinical Research Services

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

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.

Global Reach

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

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.

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.

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.

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.

Auditing

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

Training

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».

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.