EXCEEDING YOUR EXPECTATIONS

Owners

Goods & Services

Regulatory affairs, namely, reviewing standards and practices to assure compliance with clinical trial laws and regulations

Pre-clinical to phase four clinical trial management services, namely, pre-study document collection and review, site selection, visits and audits, site compliance, project tracking and monitoring reports, negotiation and administration of investigator grants, labeling, packaging, distribution, coordination and tracking of clinical trial products and materials, regulatory document processing, central laboratory selection and coordination; pre-clinical to phase four clinical trial management services, namely, managing site and study-specific subject recruitment strategies and programs in the nature of contingency strategies and solutions to address specific project challenges; pre-clinical to phase four clinical trial management services, namely, managing the development of all study related documents and materials in the nature of study protocols, amendments, paper and electronic case report forms, informed consent forms, diary cards, safety narratives, presentation posters, technical briefs and training manuals; pre-clinical to phase four clinical trial management services, namely, managing all aspects of study, drug reconciliation, and inventory and distribution reports, managing all aspects of clinical trials, namely, managing investigators, technicians, and participants, ethical reviews, investigator meetings, databases, statistical analyses and reporting, randomization logistics, medical writing services, recruitment of investigators, technicians and participants; providing data management services in the medical, pharmaceutical and biotechnological field

Providing training in the field of clinical trials and clinical trial management for the pharmaceutical and biotechnological industries

Clinical supply storage in the field of clinical and medical supplies

Medical and scientific research consulting regarding pre-clinical to phase four clinical trials; providing quality assurance services in the pharmaceutical and biotechnological industries