Redefine your Phase IIB/III clinical trials.
Customized solutions for transforming the clinical trial landscape.
Worldwide has customized Phase II-IIIB clinical trial services, deployed as a full-service CRO solution.
We create scalable, flexible programs based on experiences with other programs ― across therapeutic areas — that help avoid pitfalls.
Keep your NDA submission on track
We have been operating and delivering study results for almost 20 years and have the experience, the expertise, and the proven ability to accommodate all your clinical pharmacology studies.
Operationalize your clinical studies for the right patients.
We strive to improve patient access to clinical trials. In today’s highly international clinical trial environment, local knowledge is essential to power global solutions. That’s why our clinical experts recognize and utilize regional differences in standard of care, such as language and culture.
Plan your commercialization early for market success.
We can assist you in completing trials to define product characteristics, explore quality of life and healthcare utilization issues, devise marketing strategies that recognize global standard of care disparities, and prepare for Phase IV evaluations.
How can we craft your vision?
Data Management
Our clinical pharmacology unit and integrated bioanalytical laboratory are located near each other to allow for rapid sample processing and data generation.
Tools & Technologies
Our team is constantly on the lookout for efficiencies and opportunities to make your data, budget, and efforts go further through strategic planning and proactive communication with regulatory and program stakeholders.
Drug Depots
We understand that the end goal doesn’t exist in a vacuum; it involves hitting strategic targets throughout the program. Our inhouse teams are diverse in knowledge and background, with the expertise needed to partner with you at every step of your program.
Drug Safety & Pharmacovigilance
Our approach to drug safety is based on a documented process grounded in strong clinical knowledge, good pharmacovigilance practices, and extensive clinical development expertise.
We have a mature global footprint — and a wealth of experience to support it.
Global Regulatory
Our team is constantly on the lookout for efficiencies and opportunities to make your data, budget, and efforts go further through strategic planning and proactive communication with regulatory and program stakeholders.
Medical Writing
Our Medical Writing staff are all members of the American Medical Writers Association. They specialize in developing clinical regulatory submission documents such as protocols, investigator brochures, informed consent forms, and clinical study reports.
Additionally, they manage IND submissions and coordinate document publishing for eCTD compliance.
Medical Monitoring
Our Medical Monitors are experienced clinical development professionals. Strategically located across various time zones, they provide timely support to sites and investigators.
Patient Recruitment and Retention
We offer patient recruitment and retention services that are tailored to meet the needs, indications, and timelines of your study.
Our global study coordinators help overcome the challenges of global trials, ensuring successful patient recruitment while adhering to local regulations and cultural demands. Retention strategies are included in our protocol to reduce patient dropout.
Project Management
Our Project Management team provides comprehensive support and guidance throughout your clinical trial. Your therapeutically-aligned Project Director ensures the capture of all relevant data with clinical and medical integrity, offering operational solutions to any project challenges.
Our team’s involvement begins with the proposal and continues until the end of your study, ensuring on-time delivery with quality and risk mitigation.
Feasibility and Protocol Development
Our global feasibility experts offer top solutions for your clinical research program. We integrate methodological rigor and operational acumen into protocol development, from early trials to peri-approval investigations.
Quality Assurance
We don’t rest on our well-earned reputation for high-quality or relax our ideals. We treat every project as an opportunity to apply lessons learned and excel again.
We promote continual process improvement and provide thorough QA training and policy. Our experienced quality management specialists offer QA consulting and audits in local languages. As a gold-level member of CDISC, our work adheres to CDISC standards.
Rater Services
Our Clinical Assessment Technology (CAT) team is a fully-integrated part of our study team that helps enhance signal detection by improving the quality of sites, the quality of patients, and the quality of the outcomes data.
This team offers several benefits, including site selection based on CAT input, seamless communication between team members, elimination of external rater reliability vendors, and faster site and study startup processes.
See What Worldwide Clinical Trials Can Do For You.
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