Clinical Research Services Overview
QPS provides comprehensive clinical research services to support drug development across all phases, with a particular emphasis on Phase II-IV clinical trials and medical device studies. Our global presence, with offices in the USA, Austria, Croatia, Czech Republic, Germany, India, Netherlands, Spain, and Taiwan, ensures local expertise combined with international reach.
All clinical research services are conducted in adherence to International Conference on Harmonization-Good Clinical Practice (ICH-GCP) standards and all applicable regulatory requirements. This commitment to excellence ensures that we deliver high-quality outcomes for pharmaceutical and scientific clients worldwide.
QPS Global Clinical Trial Expertise
At QPS, we deliver a broad range of clinical trial services tailored to support drug development at every phase. Our expertise spans early-phase trials to post-marketing studies, ensuring robust data and efficient execution. With a commitment to excellence, we offer a comprehensive suite of clinical research services, including:
- Phase I - IV Trials: Comprehensive trial management for every clinical development stage.
- First-in-Human Trials: Safely transitioning innovative therapies from preclinical to clinical stages.
- Pharmacokinetics & Pharmacodynamics: Studying how drugs interact with the body and their mechanisms of action.
- Bioavailability & Bioequivalence: Measuring absorption and efficacy of pharmaceutical formulations.
- Drug-Drug Interaction (DDI) Studies: Assessing safety and efficacy when drugs are combined.
- Food Effect Studies: Evaluating how food impacts drug pharmacokinetics.
- Single & Multiple Dose Escalation (SAD/MAD): Determining optimal dosage levels through rigorous study protocols.
- Efficacy Endpoints: Precise evaluation to ensure trial outcomes meet regulatory and scientific benchmarks.
- Bridging Studies: Ensuring clinical data applicability across diverse populations.
- Post-Marketing Studies: Supporting the safety evaluation of drugs after they reach the market.
By leveraging our global network and scientific expertise, we provide end-to-end solutions for your clinical trial needs.
QPS Phase I-IV Clinical Services
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QPS Global Clinical Research Services
QPS is your trusted partner in delivering comprehensive clinical research services. Our team of experts offers customized solutions to ensure regulatory compliance, operational efficiency, and scientific excellence. Our services include:
- Project Management: Delivering seamless communication and coordination to keep your studies on time and on budget.
- Site Identification & Qualification: Carefully assessing and selecting clinical trial sites that meet your study needs to ensure success.
- Study Design: Crafting scientifically sound studies tailored to your objectives.
- Protocol Writing: Developing clear and compliant clinical trial protocols.
- Subject Recruitment & Management: Ensuring timely and efficient enrollment of healthy volunteers and/or patients, with a focused approach to ensure the wellbeing of every study subject.
- Study Monitoring: Ensuring protocol adherence and participant safety at every step.
- Medical Affairs: Providing expert medical oversight and insights throughout your clinical research journey.
- Medical Monitoring: Offering proactive medical oversight to address emerging issues during trials.
- Regulatory Affairs: Navigating complex global regulatory landscapes from investigational new drug (IND) application to final new drug application (NDA) submission to ensure timely approvals.
- Biostatistics: Applying advanced statistical methodologies to support reliable and actionable trial outcomes.
- Data Management: Managing and analyzing clinical data with precision and speed.
- Quality Assurance: Upholding the highest standards to ensure data integrity and compliance.
With a global network of sites and key opinion leaders (KOLs) and a proven track record of success, QPS is uniquely positioned to support your clinical research objectives from inception to completion.
Comprehensive Clinical Research Services
At QPS, we are committed to delivering a full spectrum of clinical research services that cater to the unique needs of our biotech and pharmaceutical clients. Our expertise spans every aspect of clinical trials, ensuring seamless execution, regulatory compliance, and reliable results. From the development of clinical trial kits to advanced project management and site selection processes, QPS is your trusted partner for clinical research success.
Below are some of the key services we offer to support your clinical trials:
Project Management and Site Monitoring
The QPS clinical trial monitoring and management teams are an integral part of the successful completion of any clinical research project. They ensure that trials are ethical and efficient and produce valid, reliable data.
Data Management
Data management for successful clinical trials. Data management is a fundamental element of a successful trial. This step is critical to your success.
Clinical Trial Kits
QPS has added a new capability, building clinical trial kits. We offer individualized service, fast turnaround times, and can ship to any global clinical trial site. Contact Us (link to contact form) for more information.
Pharmacovigilance
At QPS, we have systems in place to enable the identification, recording, reporting and analysis of safety information so that any safety signals that arise during a trial are quickly identified and acted upon.
Medical Writing
High-quality medical writing is important to the regulatory success of our clients. Our medical writing writers have the therapeutic expertise necessary to deliver high-quality written material.
Links to Relevant Documents
- Efficiently Performing Two Global Approval Studies in Prostate Cancer Patients
- Phase II-IV Clinical Overview
- Phase II-IV Clinical Services & Locations
- Early Phase Clinical Overview
- Expedited Study Delivery – Logistics
- Expedited Study Delivery – Pharmacy
- Studying Sedatives in Phase I Studies
- Pharmacokinetic Studies in Patients
- Corporate Overview Clinical Sites
Testimonials
Such a high-quality submission, followed by a similarly high-quality pre-clinical, non-clinical and CMC program, along with high-quality QC, organization, summaries and interpretation of dozens of reports; all accomplished just about a year after we nominated the clinical candidate.
Thank you for your contribution to the successful delivery of this historic company milestone.