PCO's Mission
To execute clinical trials with a focus on excellence, quality, compliance, and cost-effectiveness
ABOUT PRECISION CLINOPS
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Precision ClinOps LLC (PCO) was founded in 2021 by an experienced group of clinical research professionals with extensive years of clinical trial experience
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A private company based in Colorado with completely virtual operations
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Founded in 2021 to run a small clinical trial for a Sponsor with limited resources. The clinical trial was executed successfully during the COVID 19 pandemic and resulted in high quality data resulting in FDA clearance of an in-vitro diagnostic device (IVD) for use in asthma
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PCO has completed another trial for the same Sponsor for a new version of the IVD
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PCO can conduct all Phases of clinical trials in the US for Sponsors and Academic Institutions
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PCO delivers clinical trials from concept to Clinical Study Report (CSR)
OUR FOCUS
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US based Phase 1, 2, 3 studies including first-in-human studies for Pharmaceuticals, medical devices, and in-vitro diagnostics
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PCO can undertake studies across a wide range of therapeutic areas including respiratory, internal medicine, neurology, and oncology
WHY PRECISION CLINOPS
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Cost: By operating virtually and maintaining an extremely low overhead, PCO can execute studies at a substantially lower cost compared to traditional Contract Research Organizations
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Timeliness: reduced timelines to key milestones e.g., time to First Patient In (FPI) to Clinical Study Report (CSR) completion
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Personalized approach: Our knowledgeable and experienced team remains dedicated to each project giving it maximal attention with low turnover of assigned personnel. This contrasts with other CROs where large projects take priority and staff are often replaced during a study
WHY IS PCO COST-EFFECTIVE?
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PCO is a total virtual operation with low overhead
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PCO assembles a team of experts tailored towards the needs of the project including site monitors, medical monitor, data managers, clinical project managers, regulatory experts, financial oversight experts, and biometric experts
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PCO identifies Clinical investigators, vendors e.g., biostatisticians, EDC providers, laboratory services and negotiates with site and vendors on behalf of the Sponsor
Services
Clinical Development Strategy
Clinical Operations: A to Z
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Support Regulatory Submissions
Testimonials
Ryan Leard
“Precision ClinOps (“PCO”) has been an excellent choice of Clinical Research Organization for Caire Diagnostics. Since 2020 I have worked with PCO as a full service CRO for two clinical trials for our in-vitro diagnostic device (“IVD”). Based on a highly successful outcome for the first trial they ran (FDA clearance of our Fenom Pro device), we have engaged them to lead our second trial. After inviting proposals from several of the typical and other small CROs available, PCO is the most efficient team I have had the privilege to work with."
Executive Team
Philip E Silkoff, MD
Head of Clinical Development
Phil is the Managing Director for PCO. He is a board certified pulmonologist with over 20 years experience in industry prior to which he was in academia. His passions are clinical trial design and clinical operational excellence. Phil is based in Boulder Colorado.
CLINICAL OPERATIONS TEAM
Kelley Collins-Winters, RT(R), BS, MBA, Associate Director of Clinical
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Kelley Collins-Winters began her research career in 1994 as a Clinical Research Coordinator. Since 1994, her scope and responsibilities have increased to include the following roles: Associate Director of Clinical Operations, Senior Manager of Clinical Operations, Senior Manager of Clinical Monitoring Services, Project Manager, Clinical Manager, Clinical Research Associate, Quality Assurance Auditor, and Data Manager. Currently she serves as a Associate Director of Clinical Operations at Precision Clinical Operations. Ms. Collins-Winters has experience in the following therapeutic areas across phases I through IV clinical trials: Dermatology, Gynecology/Obstetrics, Musculoskeletal, Oncology, Neurology, Infectious Disease, Gastrointestinal, Respiratory and Psychiatry. She has conducted studies in the US, Canada, Australia, and Europe. Ms. Collins-Winters has an MBA and a BS in Psychology, both from California Coast University in Santa Ana, California. Ms. Collins-Winters is registered as a Radiologic Technologist through the American Registry of Radiologic Technologists (ARRT). Also, she is a licensed esthetician in Texas.
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Ming Lee, Senior Manager Clinical Operations
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Clinical Project Manager with over 8 years engaging in design and operational activities of Phase I safety trials, bioavailability and bioequivalence studies to ensure efficient enrollment and trial execution. Over 8 years of experience providing trial management services in the design and execution of complex trials (Drug and Medical Devices), which include overall budget management oversight, vendor selection [e.g., Central Labs, Electric Data Capture (EDC), Actigraphy], and data management (System Validation and Quality Oversight).
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Vani Bhagwat, Lead CRA
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Accomplished clinical trial professional with over 11 years of direct experience managing all aspects of clinical trials from study start-up to close-out. Over 6 years of experience as a pharmacovigilance professional achieving high-quality and productivity in clinical trials.
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Xavier Alcala PhD, Senior Clinical Research Associate
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Since 1998, Javier has been engaged in clinical operations. Duties have included general monitoring activities, maintaining the Regulatory Binder, drug accountability, pre-study, monitoring and close out visits. Participated in over 50 trials, 13 of which have been bilingual placed in multiple countries. In addition, since 2007 he has been an independent auditor and CTM consultant auditing several studies in Latin America, Europe and USA.
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Mayan Silkoff RN, Clinical Research Associate
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Mayan is a dedicated intensive care nurse with over 6 years of clinical trial experience, specializing in Phase I to Phase IV studies. She has an extensive background in managing trials across a variety of medical fields, including asthma, allergy, immunology, neurology, and dermatology. Her comprehensive expertise and commitment to patient care ensure the highest standards of clinical practice and research integrity. Mayan's multifaceted skills contribute significantly to advancing medical knowledge and improving patient outcomes.
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