Ockham operates with a single goal: meet or exceed sponsor expectations, regardless of challenges.
We succeed by consistently and carefully:
- Sustaining a commitment to the highest quality of service
- Listening and working toward complete comprehension of Sponsor's request
- Matching employees to assignments in the most effective way to meet specific sponsor needs
Ockham's Clinical Management and Clinical Development Services
Ockham Oncology provides focused, customer-driven guidance to biotechnology and pharmaceutical clients across a wide range of services, including: regulatory processes, medical writing, data and project management, monitoring, safety, and may more.
Clinical Consulting Services
Ockham Oncology provides study-specific expertise and best-practice recommendations for several key processes, including: regulatory pathway evaluation, approval-oriented drug development planning, scientific due diligence related to partnered compounds, project management and auditing, international regulatory representation and compliance, and many others.
Clinical Trial Management Services
Ockham Oncology provides compound and drug approval runway services, including:
- Clinical monitoring, which include site qualification, documentation, management and site close-out, and more
- Medical writing for proposals, EFD pre-meeting packages, advisory committee briefings, regulatory strategy presentations, clinical study reports, FDA meeting minutes and many others
- Comprehensive project management for such processes as grant negotiation and payment, budget and timeline oversight, communication, CRA oversight and project team operations
- Data Management structure and management include CRF design, database design and deployment, data validation query and archiving
Electronic Data Capture (EDC)
Ockham Oncology provides oversight for clinical trial study design and execution to meet regulatory and business objectives though multi-stage statistical analysis and reporting. This work ranges from development, manufacturing and marketing of compounds to presentation of statistical data to regulatory authorities. In addition, Ockham Oncology offers advice across the full research spectrum from discovery, to Phase I-IV trials, clinical development and go-to-market recommendations.