Early Phase/Phase I Development
The success of your novel therapy relies on maintaining control and consistency throughout the compounding processes, from in-process testing to batch release. This ensures you receive reliable data delivered on time and within budget, with meticulous attention to standards for pharmaceutical research and practice. Worldwide Clinical Trials was acknowledged for these characteristics, greatly exceeding customer expectations with regard to data quality and cost, as outlined in the latest Early Phase CRO Quality Benchmarking Report conducted by Industry Standard Research. We work closely with each client to understand their expectations and timeline, ensuring that a quality product is delivered on time. We work to fully understand your program so we can meet or exceed expectations. In addition, if changes in your program occur, we are nimble and flexible, enabling quick adjustments in a reasonable timeframe. We know your program won’t wait for us, and we don’t expect it to.
Our on-site pharmacy has an ISO Class 7 clean room with an ISO Class 5 laminar flow hood suitable for compounding sterile product. In addition to the clean room, a compounding suite is ready for oral and topical dosage form preparations.
We go above and beyond operational norms – and our customers notice. More than 25% of respondents in ISR’s Early Phase CRO Quality Benchmarking Report stated that Worldwide’s operational excellence exceeded their expectations. Our Phase I pharmacy operates according to standards set by United States Pharmacopoeia (USP) 797, US Food and Drug Administration (FDA), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP) guidance for Phase I investigational drugs, providing you with the confidence you desire in a CRO partner.
Our experienced team of pharmacists and pharmacy technicians are available to provide advice and scientific consultation. Completing the team, our quality control professionals ensure accuracy of documentation, dispensing, and inventory.
Make informed decisions, faster with Worldwide Clinical Trials’ Bioanalytical Laboratory