In order to provide the industry-leading level of quality and project management our Sponsors have come to rely upon, Ockham recognizes that ongoing education and training is essential for its personnel. In addition to traditional education, Ockham also sponsors regular, weekly lunch and learn training programs. These required tutorial seminars are prepared and presented by both in-house and external academic and industry experts in the topic or field covered. Some programs are project-focused, while others have the broader goal of general resource development.
Topic Group: Therapeutic Area
- Raynaud’s Phenomenon: Characteristics and Treatment
- Understanding Cancer
- Ovarian Cancer
- Treatment of Solid Tumors
- Treatment of Solid Tumors (part 3)
- Glioblastoma
- Glioblastoma: Introduction to Brain Tumors
- Glioblastoma: Classification and Staging
- Glioblastoma: Treatment
- Psychiatry: Diagnosis and DSM IV
- Psychiatric Tests & Instruments
- Bipolar Illness
- Treatment of Bipolar Illness
- Dementia: Introduction
- Domains of Memory and Cognition
- Leukemia 1: ALL, AML, MDS
- Leukemia 2: CML, CLL, CMLB
- Acute Myeloid Leukemia and Myelodysplastic Syndrome
- Ulcerative Colitis
Topic Group: Regulatory
- Human Participant Protections Education for Research Teams
- Responsibilities of Sponsors and Investigators (GCP and CFR)
- Regulatory Topics: HIPAA
- Institutional Review Boards (21 CFR Part 56, ICH)
- Drug Safety: SOP/WPD Overview
- Informed Consent Process
- Drug Development Life-Cycle
- Regulatory Aspects of Device Trials
- CFR Part 11
- Regulatory Reporting of SAEs
- ICH GCP: Investigators
Topic Group: Safety Monitoring & Regulatory
Identifying SAEs and the CFR
Topic Group: Safety Monitoring
- Understanding and Monitoring Lab Results
- Understanding and Monitoring Lab Results
Topic Group: General/Regulatory
What is Validation? 21 CFR Part 11
Topic Group: General Clinical
- RECIST: Response Evaluation Criteria in Solid Tumors
- Hypertension: Diagnosis and Treatment
- Hypertension: Diagnosis and Treatment (part 2)
Topic Group: resource Development
- Do’s and Don’ts of BD Presentations
- Information Technology and Filing
- Introduction to Biostatistics
- Data Management: SOP/WPD Overview
- Influenza: Introduction
- Insomnia: Differential Diagnosis and Management
- Atherosclerosis
- Coding of Adverse Events
- Biotechnology Development: Overview of Regulatory Milestones and Other
- Considerations
- CTD: Overview and General Considerations
- Training Files
Topic Group: Clinical
- ICH GCP: Principles & IRBs
- Safety Data Reconciliation
- Test Article Accountability for IP
- Clinical Study Documentation
- The CSR
- Research Misconduct
- What is Source Documentation?
- The CRO-Site Relationship
- Data Listings Review: AEs, Medical History
- Generic Drug Approval Process
- Vital Signs
- ECG Interpretation for the Non-Clinician
- Audits, Compliance, and Internal Quality
- Glioblastoma: Diagnosis, Classification, Staging
- Auditing and Ethics 101
- Informed Consent
- Sponsor Responsibilities and Safety Management
Topic Group: Statistics
Current Trends in Analytics
Topic Group: Policies/Procedures
- Business-Related Travel & Reimbursement
- Drug Safety: SOPs
- Disaster Recovery
- Clinical SOPs
- Global SOPs
Topic Group: Project Specific
- Atherosclerosis: Introduction
- Alzheimer’s Dementia Protocol Training
- Chronic Obstructive Pulmonary Disorder (COPD)
- Mild Cognitive Impairment Protocol Training
Topic Group: Multidisciplinary
Protocol Violations, Deviations, & Waivers: Who is Your Customer?