Talent Sourcing | FSP Partnering | Project Delivery
Customized clinical solutions to help you scale and meet critical operational demands seamlessly.
HOW WE HELP
By combining our 20+ years of clinical services expertise with our established network of trusted clinical scientists, medical and clinical monitors and other functional specialists and managers, we deliver unique service solutions that close skill gaps, improve operations, and allow our valued clients to rapidly scale and deploy resources according to strategic needs. Partnering with us, clients have seen shortened clinical trial timelines and greater success in their regulatory submissions.
Clinical Services Offered
Functional Service Provision
(FSP)
Staff Augmentation & Subject Matter Experts
Outsourcing & Project Services (FSO)
Functional Capabilities
Research & Development
Preclinical Development
Nonclinical
Pharmacology
Toxicology
Clinical Study Design Systematic Literature Review
Biostatistics/Data Science
Pharmacometrics (PK/PD, ADME)
AI-Based Data Synthesis and Analysis
Operations
Clinical Study Management
Site Qualifications
Site Initiation
Study Monitoring
Data Management
Site Closeout
Trial Master File/Electronic Master File
Audits
Services
Pharmacovigilance & Drug Safety
PMCF Strategy and Design
Clinical Regulatory
Medical Writing (Clinical Evaluations,
CSRs, IBs, ICFs, Abstracts, Publications,
and more)
Our Consultant Network
Individual contributors and subject matter experts to fill your skill and expertise gaps
Research & Development
Clinical Research Physicians
Clinical Scientists
Clinical Pharmacologists
Nonclinical Subject Matter Experts
Biostatisticians
Data Scientists
Clinical Development (MD, DO)
Medical Science Liaisons (MSL) (KOL relationships)
Operations
Medical Monitors
Clinical Research Coordinators (CRC)
Clinical Trial Associates (CTA)
Clinical Research Associates (CRA)
Clinical/Medical Monitors
Clinical Trial Managers (CTM)
Clinical Project/Program Managers (CPM)
TMF/eTMF Specialists
Clinical Data Managers (CDM)
Clinical Data Associates (CDA)
Post Market & Support
Medical Writers
Pharmacovigilance Specialists
PMCF Specialists
Systematic Literature Reviewers
Clinical Regulatory Specialists
Clinical Evaluations Specialists
Meet the Team
Ben Locwin
Chief Scientist and Director of Program Services
Ben is the guiding force of Black Diamond’s service program business, blending keen technical insight with a whole picture view developed from 25 years of pharma and med device industry experience that produces impactful service solutions for customers.
Ben is the guiding force of Black Diamond’s service program business, blending keen technical insight with a whole picture view developed from 25 years of pharma and med device industry experience that produces impactful service solutions for customers.
Paul Niklewski, PhD
Medical Affairs Officer and Director of Clinical Services
Paul’s understanding of the day-to-day operational and long-term strategic goals of clinical science organizations is grounded in his 30 years working for and consulting to R&D and clinical organizations at leading life science companies. His experience is complimented by appointments as an Associate Professor at the University of Cincinnati, College of Medicine and Department of Pharmacology and Systems Physiology and as adjunct faculty for Health Economics and Clinical Outcomes Research at Xavier University’s Department of Health Service Administration.
Paul’s understanding of the day-to-day operational and long-term strategic goals of clinical science organizations is grounded in his 30 years working for and consulting to R&D and clinical organizations at leading life science companies. His experience is complimented by appointments as an Associate Professor at the University of Cincinnati, College of Medicine and Department of Pharmacology and Systems Physiology and as adjunct faculty for Health Economics and Clinical Outcomes Research at Xavier University’s Department of Health Service Administration.
Elaria Isabella Meshreky
Senior Manager, Clinical Services
Elaria has led strategic development for Black Diamond’s clinical and regulatory services operations for the past 5 years. Prior to joining Black Diamond, Elaria worked in academia on neuroscience research and as a clinical sciences consultant to small biotech companies developing pain management therapeutics. Combining her academic acumen and real- world practical experience, Elaria has helped Black Diamond clients strategize for upcoming trials, meet their IND/NDA/501k submission milestones, and accelerate their path to market To date, Elaria has helped clients with 11 marketed products to approval from pre-clinical.
Elaria has led strategic development for Black Diamond’s clinical and regulatory services operations for the past 5 years. Prior to joining Black Diamond, Elaria worked in academia on neuroscience research and as a clinical sciences consultant to small biotech companies developing pain management therapeutics. Combining her academic acumen and real- world practical experience, Elaria has helped Black Diamond clients strategize for upcoming trials, meet their IND/NDA/501k submission milestones, and accelerate their path to market To date, Elaria has helped clients with 11 marketed products to approval from pre-clinical.
Jacquelyn Numbers Hauser
Senior Manager, Clinical Services
Jacquelyn has been an integral part of Black Diamond Networks clinical service program since it’s inception, running field operations for the past 4 years. Her robust clinical research background and theoretical knowledge gained from her degree in biological science have been instrumental in her understanding of and responding to the needs of Black Diamond clients in the clinical services sector.
Jacquelyn has been an integral part of Black Diamond Networks clinical service program since it’s inception, running field operations for the past 4 years. Her robust clinical research background and theoretical knowledge gained from her degree in biological science have been instrumental in her understanding of and responding to the needs of Black Diamond clients in the clinical services sector.
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