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Our Clinical Development Team combines scientific expertise, open communication and trust to build lasting relationships with our clients. We offer collaborative solutions throughout the entire clinical development process to provide you with high enrollment rates, industry-best timelines, high-quality data, and a competitive price. Our services include:
Industry-Leading Phase I Capabilities
Moving quickly and safely through Phase I trials is critical for establishing your clinical development success. Our Phase I research capabilities feature more than 500 beds across six strategically located facilities on three continents. All Phase I sites are staffed by expert Clinical Pharmacology Teams that routinely conduct hundreds of Phase I/IIa studies annually. We also have scientific expertise in the design of all types of Phase I studies, as well as the interpretation of study data.
Our Phase I sites include:
- 58 beds in Groningen, The Netherlands
- 40 beds in Taipei, Taiwan
- 92 beds in Hyderabad, India
- 240 beds in Springfield, Missouri, USA
- 75 beds in South Miami, Florida, USA
- 20 beds in Hollywood, Florida, USA
Early Clinical Development
In addition to one of the world's largest Phase I site offerings, we provide fully integrated services to seamlessly move your project through early clinical development. Our expert staff use disciplined processes to supply accurate, superior-quality data so you can make confident decisions - earlier and faster.
Our full range of early clinical development services include:
- Review of Preclinical Data
- Study Design and Protocol Writing
- Clinical Conduct
- Bioanalysis/Biomarker Assays
- Provision of CDISC-compliant Clinical Study Reports
- First-in-Man Programs (SAD + MAD + FE+ CYP450 Interaction)
- Clinical PK/PD Studies
- Bioavailability Studies
- Bioequivalence Studies
- Drug Interaction Studies
- 505(b)(2) NDA Studies
- Human Mass Balance Studies
- Microdosing Studies
- Imaging (PET, fMRI) Studies
- Vaccine Studies
- Thorough QT/QTc Studies
Proof of Concept Studies
We specialize in conducting POC studies in specialty and patient populations by working either independently or together with local university and general hospitals. We also develop pharmacodynamic endpoints and laboratory biomarker assays that are critical for the evaluation of your early stage compounds, targeted for a wide variety of therapeutic indications.
Full Clinical Development
Our experienced Clinical Development Teams operate from strategically located sites throughout Europe, the United States, and Asia Pacific. In every location, we partner with you to:
- Meet or exceed your strict timelines
- Manage increasing amounts of clinical data from multiple sources and systems
- Provide access to global patient populations for efficient site startup and fully enrolled trials
- Select the investigators who will best fit your study
Our full range of clinical development services include:
Project and Program Management
QPS study managers oversee your studies, according to your own or QPS’s SOPs. These experts select the appropriate sites for your study and work closely with clinical teams at the site to ensure rapid patient recruitment and efficient study conduct, including submissions to ECs or other competent authorities. Study managers also stay in close communication with you, providing frequent updates about the status and progress of your trial.
Site Management and Monitoring
QPS’s site management & monitoring teams have vast experience in monitoring clinical studies for new pharmaceutical compounds and medical devices and will monitor your trial according to your exact requirements. Our well-trained CRAs can be located at your site, or can work from QPS' local offices.
Patient Recruitment Services
Patient recruitment is one of the most common and costly causes of delayed research timelines. To ensure your trial is quickly and fully enrolled, we have established a specialized patient recruitment group within our clinical development team. These experts provide a wide range of advice including site and investigator selection, and the development of study protocol to maximize patient recruitment and retention. We have access to a large network of investigators for all major therapeutic categories, as well as experience conducting a wide range of studies, from small, customized trials to multicenter, multinational studies.
Clinical Research Support Services
Successful management of your drug development program requires superior services that extend beyond the clinical trial site. Efficient data management, interpretation and analysis, and development of effective written materials, is vital to the success of your overall study. At QPS we provide high-quality back-end services to optimize your product’s success. These include:
You require accurate, transparent, accessible data to help you make better decisions. QPS' Data Management Group supports the conduct of your clinical trials from Case Report Form design to the timely release of a clean, high-quality study database, using Open Clinica as principal tools.
Our biometrics experts deliver clean, high-quality tables, listings and figures, using SAS as the principal (validated) software tool. Our biometricians/statisticians and statistical programmers are involved in the earliest stages of your clinical study to ensure meaningful data outputs. They focus on shortening the time from the last patient visit to database lock and statistical report.
PK/PD Analysis and Modeling
As part of our integrated Phase I services or as a stand-alone service, QPS provides clinical PK or PK/PD data analysis. We utilize either non-compartmental PK methods using WinNonlin and SAS software applications, or population PK or PK/PD modeling using NONMEM, SAS and other associated software applications. We believe that sophisticated data analyses leads to knowledge, and our team provides the expert knowledge needed to maximize your clinical trial success.
The quality of written clinical presentations plays a critical role in the success or failure of new compounds and devices. At QPS, we can help you produce a wide range of medical or scientific documentation. Turning the fruits of your scientists’ research into well written documentation enables your staff to focus on what they do best: develop new drugs and devices. Our scope of services includes:
- Study protocols and reports (Phase I-IV)
- Abstracts, manuscripts and journal articles
- Investigator brochures and annual updates
- Informed consents
- Response to clinical hold orders
- Pre-clinical study reports, expert reports and summaries
- Data Safety Monitoring Board (DSMB) manuals
- Benefit risk assessment reports
- Non-clinical ADME reports
The QPS Advantage
At QPS, we combine our proven scientific expertise with our global clinical development experience to support your study from start to finish. But it is our passion for building long-lasting relationships with our clients that sets us apart. We promote a customer-focused culture that spans our entire array of services and proudly provide:
Innovative Technology for Customized, Cost-effective Solutions
Now more than ever, you need strategies that contain costs while maintaining quality. We utilize best-in-class integrated technology to offer real-time access to data that decreases decision-making time and maximizes resources. We pair technology solutions such as Electronic Data Capture, Integrated Voice Response and Clinical Trial Management Systems into a single eClinical platform. This supplies immediate access to continuously reconciled, integrated data that increases data quality, reduces errors, and minimizes redundancy.
By combining this technology with our nimble capabilities as a specialty CRO, we provide you with customized services that save time and money. No matter how tight your budget, we look forward to finding the right solutions to fit your unique needs.
We work hard to ensure optimal communications. Each study will have a client-dedicated team, lead by an experienced Clinical Project Manager who has the overall responsibility for the conduct of your study and remains your single point of contact throughout the project’s duration. Clinical Project Managers are readily available to provide insight and guidance, and all QPS sites are connected through a global data network to simplify management of your study.