Company

Calculate - Ockham

Overview

Ockham is a Global Contract Research (CRO) and Functional Service Provider (FSP) organization headquartered in Cary, North Carolina (near the university-biotech-pharmaceutical sciences nexus known internationally as Research Triangle Park). Satellite offices strategically placed around the United States, in India and the U.K. underpin Ockham’s global customers and operations.

Ockham provides high-quality, global clinical research and strategic development services to pharmaceutical and biotechnology companies, assisting them in the achievement of their strategic planning, technology transfer, licensing, regulatory planning and submissions, pre-clinical development, and manufacturing goals.

Ockham also provides fully integrated clinical trials support in the areas of Clinical Operations, Data Management and Biostatistics, as well as Regulatory dossier compilations. In addition, it offers functional and specialty resourcing services to pharmaceutical, biotech and medical device companies that require Clinical Operations, Good Clinical Practice (GCP), Good Laboratory Practice (GLP), or Good Manufacturing Practice (GMP) auditing, Data Management, Statistical Programming, Biostatistics, and Medical Writing solutions.

Ockham currently operates two distinct business lines:

Full-Service Contract Research – Ockham is a full-service CRO offering complete Data and Clinical services, including complete Phase I-IV Clinical Trial Management services (full-service or functionally based): Project Management, Clinical Monitoring, Data Management, Biostatistics and Programming, Medical Writing, Regulatory Consulting/Liaison, and Pharmacovigilance (PVG).
Functional Service Provider - Ockham offers clients Data (SAS® / Statistics / Data Management) and Clinical (Clinical Research Associates/Monitoring, Medical Writing, PVG) – typically based in Ockham offices. Fixed-bid or Time-and-Materials (T&M) pricing models are available. Dedicated, flexible teams allow longer-term relationships with research-critical personnel and eliminate co-employment.

Ockham is fully compliant with U.S. Code of Federal Regulations (CFR) 21, Part 11.

Full CRO Solutions

Ockham offers complete Data and Clinical CRO services, including complete Phase I-IV Clinical Trial Management services, full-service or functionally based: Project Management, Clinical Monitoring, Data Management, Biostatistics and Programming, Medical Writing, Regulatory Consulting/Liaison, and PVG:

Clinical Project Management
Investigator site selection Investigator grant negotiation and payment Site Regulatory Packet, Review and Approval	Oversight of Clinical Research Associates (CRA) Review and Approval of Monitoring Visit Reports CRA Training and Co-monitoring

Clinical Monitoring
Site qualification visits Regulatory documentation collection Site initiation visits Interim site visits	Query management Site close-out visits Overall site management

Pharmacovigilance
Around-the-clock, continuous physician coverage Serious Adverse Event (SAE) processing Investigator Letters, IND Reports	SAE narratives, MedWatch, Analysis of Similar Events (AOSE) FDA reporting of SAEs

Data Management
CRF/eCRF design Database design and programming Data coding EDC system set-up	EDC User Acceptance Testing (UAT) and Reporting Validation Query management Data archiving

Biostatistics
Full support for Phase I-IV clinical trials Optimal clinical trial study designs to meet regulatory and promotional needs Statistical analysis support for studies Table / Listing production and QC	Expert consultation for statistical issues Study design and consultation Analysis plan development Interim analysis/DSMB Regulatory and advisory meeting support

Medical Writing / Regulatory
Clinical protocols Summary sections of INDs and NDAs FDA pre-meeting packages Advisory Committee meeting briefing documents IND/ NDA preparation	Integrated summaries of efficacy and safety Regulatory strategy documents Integrated clinical study reports FDA meeting minutes