Services

Clinical Development / CRO Services

Ockham provides high-quality, customer-focused services to biotechnology and pharmaceutical clients, including service in the areas of:

Regulatory Affairs
Medical Writing
Clinical Monitoring
Project Management
Medical Monitoring and Safety Management
Biostatistics
Data Management
Electronic Data Capture

Ockham services are distinguished by the level of experience and expertise possessed by the company’s veteran resource, a focus on customer service, flexible and reasonable project budgets, and a commitment to truly adding value to customer interactions at every step of the process.

Regulatory Affairs

Regulatory strategizing from pre-clinical through Phase IV
Interpretation of FDA/ICH regulations and guidance
Planning and facilitation of Advisory Committee meetings
Preparation of FDA Advisory Committee materials
Preparation of FDA pre-meeting materials FDA liaison meeting facilitation
Critical review of regulatory reports and documents
Preparation and submission of regulatory documents (including INDs, NDAs, and sNDAs)
Preparation and submission of annual reports

European Union (EU)

Global Regulatory strategizing from Pre-Clinical through Phase IV
Interpretation of FDA/ICH, European Medicines Agency (EMA) regulations and guidance
Full understanding of EU Clinical Trial Directive (2001/20/EC) and practical expertise in using the EudraCT clinical trial procedure
Planning and facilitation of Scientific Advice meetings with EMA and the EU Member States (MS) Competent Authorities (CA)
Preparation of FDA Advisory Committee materials
Preparation of FDA pre-meeting materials & FDA liaison meeting facilitation
Critical review of regulatory reports and documents
Preparation and submission of U.S. regulatory documents (including INDs, NDAs, and sNDAs)
Preparation and submission of EU regulatory documents, including:
- All types of Marketing Authorisation Applications (MAA) – including Centralised (CP), Decentralised (DCP) and Mutual Recognition (MRP)
- Orphan Medicinal Product Designations (OMPD)
- Scientific Advice Working Party (SAWP) requests
- Clinical Trial Agreements (CTA)
Preparation and submission of Annual Reports

Medical Writing

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

Project Management

Investigator site selection
Investigator grant negotiation and payment
Study coordination
Budget and timeline management
Communication management
Detailed clinical review
Oversight of CRAs and project team

Medical Monitoring and Safety Management

Around-the-clock, continuous physician coverage
Serious Adverse Event (SAE) processing
SAE narratives, MedWatch, Analysis of Similar Events (AOSE)
Protocol-related interactions with Investigators

Clinical Monitoring

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

Biostatistics

Optimal clinical trial study designs to meet regulatory and promotional needs
Statistical analysis support for studies conducted at all stages of drug research, development, manufacturing, and marketing
Assistance in presenting statistical methods before regulatory authorities
Expert consultation for statistical issues relating to drug discovery, formulation, laboratory development, animal studies, clinical development, evaluation/approval, manufacturing, and marketing research
Full support for Phase I-IV clinical trials Study design and consultation
Assistance with protocol development and verification of CRF design
Analysis plan development SAS programming for tables, figures and listings
Interim analysis/DSMB
Regulatory and advisory meeting support

Data Management

CRF design
Database design and programming
Data coding
Validation
Query management
Data archiving

Electronic Data Capture (EDC) Services

There are several important changes to monitoring practices associated with trials run using EDC systems. Ockham breaks these down into three distinct sets:

Set 1 - Monitoring resource Participation in EDC Design and Testing

Ockham’s experience indicates that monitoring resource must be involved with the set-up, development, and testing of the EDC system. Ockham believes that as a monitor would be involved in CRF design and review (in a paper-based study), so too should the monitor be involved in EDC through:

Review of initial eCRF design and navigation

Participation in development of EDC training for sites

Participation in User Acceptance Testing (UAT) for 21CFR Part 11 compliance testing

Set 2 - Monitoring resource Use of the EDC System During Monitoring

Ockham’s experience further suggests that a major advantage (for monitoring) of EDC is its use for pre-, intermediate, and post-visit data review by the monitor:

Prior to a Monitoring Visit – Monitor reviews all eCRFs entered at the site; notes areas of concern and uses material to develop visit plan for site:

During a Monitoring Visit

Monitor reviews data with site personnel and uses review to facilitate early detection of data issues; monitor also works with site personnel on eCRF training and compliance issues After a Monitoring Visit

Monitor reviews eCRF for timely eCRF entry (by site) and query responses

Set 3 - Monitor Management and Interaction with Site Personnel

Ockham believes that the monitor must link management to eCRF completion. This link ranges from ensuring that site compensation is associated with eCRF completion to day-to-day management of query resolution.

Each of these EDC-specific procedures is embedded in all Ockham Monitoring Plans. Approximately 40% of Ockham’s clinical monitoring is executed using an EDC system. Although Ockham generally does not recommend specific brands of software, it has had the best experience with etrials® and Nextrials PrismTM.