About UsGlobal capabilities. Customized approachPharmaNet works with pharmaceutical, biotechnology, generic drug, and medical device companies offering a full range bioanalytical, Phase I-III clinical trial, regulatory, and phase IV post-marketing services. With a breadth of global resources and expertise in virtually all major therapeutic areas, PharmaNet has the capacity to conduct any clinical trial, from a single local study to programs spanning multiple continents. Bioanalytical ServicesThrough two state-of-the-art GLP-compliant laboratories, an extensive list of validated assays, knowledgeable scientists and skilled technicians, PharmaNet provides bioanalytical services for projects of any size throughout the drug development process. Our expertise includes non-GLP bioanalysis, custom assay development and validation, LC/MS, GC/MS, biomarkers, immunochemistry and cell based assays. Phase I-IIa Clinical TrialsWith a full range of services from study design to regulatory submission, as well as our own dedicated clinical facilities, PharmaNet provides everything you need for successful phase I-IIa clinical trials. Our physicians and experts in quality assurance, clinical pharmacology, data analysis and reporting, and regulatory affairs will custom fit a program specifically for you. Phase IIb-III Clinical TrialsIn addition to decades of experience in clinical trial design, PharmaNet offers a flexible management style that brings together exactly the team you need to succeed, including experts in oncology, cardiology, neuroscience, nephrology, dermatology, ophthalmology, vaccines, biologics/biosimilars, pediatrics and other therapeutic categories. A full range of services including data management and biostatistics are available for trials of any size. Phase IV Clinical TrialsBecause the post-approval environment is so different from clinical phases, PharmaNet has a dedicated suite of services and a team of experts to guide you through the process while skillfully addressing the needs and concerns of clients, patients, providers, payers, and government regulators. In phase IV clinical trials, PharmaNet provides the vision and clarity you need to make smart – and profitable – post-approval marketplace decisions. ConsultingTo help you anticipate needs, manage risk and react to changes in the regulatory environment, PharmaNet has assembled an exceptional team of regulatory and pharmaceutical experts, including former senior level officials from the FDA and other international regulatory agencies, with proficiency in clinical development, planning and execution, and regulatory submissions from pre-IND to marketing applications, regulatory pathways, fast track approvals, post-marketing support, biosimilars and more. Quality AssuranceQuality is integrated into all of our practices. The PharmaNet QA team will interact directly with you to understand your specific requirements in your clinical study or drug development project. Together, our quality and regulatory affairs specialists oversee conformance with requirements and any applicable regulations such as U.S. Food and Drug Administration (FDA) regulations, Canada’s Health Products and Food Branch Inspectorate regulations, European Union directives, ANVISA and other applicable international agencies’ regulations during each phase of the clinical trial process. Our experience and oversight ensures that our clinical and bioanalytical services comply with applicable Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and International Conference on Harmonisation (ICH) GCP guidelines (E6). StaffingWhen you need highly skilled clinical development professionals with specific therapeutic and functional expertise, talk to PharmaNet. PharmaNet Resource Solutions offers a variety of staffing solutions from one talented individual to a team of any size to help you manage the staffing requirements for your project. Therapeutic ExpertiseAs one of the first CROs to establish dedicated therapeutic teams, we have specialized resources with the necessary operational and therapeutic expertise to conduct clinical programs in key therapeutic areas. By concentrating the attention of experienced medical and scientific professionals in specific areas, we have gained a depth of knowledge, which has allowed us to apply new insights and innovative science to clinical trials. |
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