Oncology Services

As a data-driven CRO, Ockham Oncology understands the need to utilize information in the most relevant framework. Data Management services include biometrics and biostatistics used to manage clinical trials with precision.

Biometrics

• Logistical Planning – Ockham Oncology facilitates data collection and reporting for critical path decisions in the complex oncology arena.
• Electronic Data Capture (EDC) – Our technical data managers have broad experience in both our Technology Transfer platform (Merge eClinical and eCOS) and other EDC systems contracted by our sponsors such as Medidata RAVE and Oracle InForm.
• Case Report Form (CRF) Design by a Data Management team experienced with CDASH and CDISC standards – including development of well-documented, focused CRF completion instructions to ensure consistency and accuracy of data across the life of your clinical trial. Our team focuses on adaptive design techniques with the expectation of minimizing the impact of mid-study changes.
• Edit Check Design to maximize identification of incomplete and discrepant data at the point of entry. Edit checks and messages are programmed and a specification report exported for review of completeness and accuracy by our internal team and the sponsor. Once changes are incorporated, final, documented User Acceptance Testing (UAT) is performed.
• System Integration of IxRS, clinical imaging management systems, electronic patient diaries and other technologies is coordinated by the Data Management team in collaboration with other functional areas including the development of requirements specifications for design of application and interfaces.
• User Acceptance Testing to provide objective evidence to ensure completeness and accuracy based on the study protocol and other key study documents.
• Data Management Plan contains details of data collection processes and systems used on your study, including activities required by each functional team to ensure the overall integrity of the study database throughout the study. Our Data Management team works proactively in the early planning phase to vet various complex data issues common to oncology trials with both our internal project team as well as our sponsors. Our motto: No surprises.
• Data Review by a seasoned Data Management team with an average of 12+ years direct pharmaceutical experience and an average of 10+ years in a various oncology indications. Our data managers are the bridge between the clinical operations and biostatistics teams, ensuring that (1) the data accurately reflect what occurred in the field and, (2) the data are accurately presented in analysis displays. We monitor data retrieval throughout the study to ensure that data is current and accurate, locking patients down as they discontinue to minimize time to lock after LPO.
• Medical Coding using MedDRA and WHO Drug dictionaries (versions maintained to meet your requirements). Our data coders have performed coding as part of data management services as well as post hoc as required for specific client requests (e.g., ISS, marketing information for data not previously coded, re-coding of legacy studies, supplement coding team for large programs).
• Electronic Data Transmission Management including developing specifications and coordinating programming and testing activities, as required, for integration of data from third-party vendors into the study database.

Biostatistics

• Full Support for Phase I-IV Clinical Trials. Study design and consultation with emphasis on early-phase (e.g., dose escalation) and adaptive trials. Our experienced statisticians are committed to providing you with optimal clinical trial study designs to meet both regulatory and promotional needs.
• Expert consultation for statistical issues relating to drug discovery, formulation, laboratory development, clinical development, evaluation/approval, manufacturing, and marketing research.
• Regulatory Assistance in presenting statistical methods before regulatory authorities.
• Protocol Development and verification of CRF design to ensure that data is collected in a manner to facilitate optimal statistical methods.
• Randomization – Our statisticians consult and generate randomization schemes to meet your study requirements using an array of methods.
• Statistical Analysis Plan (SAP) development – In concert with your focus and requirements, our expert statisticians provide a detailed analysis plan highlighting the methods and derivations in an a priori (from the earlier) fashion.
• Statistical Programming support for all phases of clinical trials. Our team of highly qualified and experienced statistical programmers provides all statistical output required according to the SAP and ad hoc requests. Additionally, our skilled team of programmers have performed CDISC SDTM/ADaM conversions for large programs consisting of several Phase I-III trials with data collected in a variety of formats.
• Interim Analysis and Data Monitoring Committee (DMC) – Ockham Oncology provides full statistical and programming support for interim analyses and/or DMCs in either a fully blinded or unblinded manner, depending on your study requirements.
• Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) for NDA Submissions. Our statisticians and statistical programmers are well-versed and experienced in providing critical statistical and programming support for NDAs and sNDAs.

Medical Affairs is a broad category addressing medical monitoring services as well as global pharmacovigilance issues pertaining to safety, surveillance and registration practices.

Medical Monitoring

• Global Medical Monitoring services
• Protocol Development assistance
• Dose Escalation and DLT/MTD activities
• Drug Safety Monitoring Board participation
• Medical Consulting services

Global Pharmacovigilance

• Global Safety Reporting
• ICSR and SUSAR Reporting through EudraVigilance
• Legal Representation in EU for Registration with the European Medicines Agency (EMA)
• Medicinal Product Registration with EMA
• Post-Marketing Surveillance
• Oracle Argus Safety Database

Scientific, Tailored Feasibility

Ockham Oncology offers clients reassurance by enrolling targeted patient populations through channeled feasibility assessments. We pride ourselves on accurate projections of recruitment and timelines due to our scientific- and protocol-based approach. We provide local and regional insights as to the best site selections and use our up-to-date market knowledge to choose intelligently. Our experience in conducting multiple feasibilities in targeted tumor types or oncology therapeutic areas ensures quality site selection.

Local and Regional Insight

Our Scientific Affairs Group works collaboratively with you to develop robust questionnaires, based on draft protocol synopsis and design. Our clinical operations teams provide a regional insight by identifying investigators and sites with relevant experience that are motivated, committed and have access to the potential patient population.

Ockham Oncology conducts feasibility from our local country offices coordinated by a dedicated Feasibility Manager. By assessing potential investigators at the local level, we have a more accurate analysis of their workload and competing studies. Historically, our recommendations, based on feasibility analysis, have saved sponsors significant clinical development costs through enhanced protocol design modifications and reduced recruitment periods.

Market Knowledge

Relationship and proximity of the Ockham Oncology staff to the site are the most significant elements of site selection. However, due to rapidly changing therapeutic targets of oncology products they are critical for thorough and targeted feasibilities for site selection. The regulatory activity in approvals of new products and in the removal of other products from the market necessitates a constant awareness to ensure the best site selection for a new study. Besides providing data to support decision-making, the report includes clear, data-driven operational strategy recommendations for the successful conduct of the trial or program.

Global Clinical Operations address our project management system utilizing a risk adapted approach, Ockham Oncology’s monitoring protocol and plans, as well as the importance of feasibility assessments for site and population selections.

Project Management

The project manager is a critical part of a study’s success. Ockham Oncology’s project managers possess proven oncology expertise and are responsible for the procedural and administrative aspects of the study as defined by the client.

Ockham Oncology project managers:

• Serve as a primary resource and point of communication for the client and study team
• Provide leadership and direction to the study team, including specifications for time, quality and cost of deliverables
• Utilize Ockham Oncology’s systems and processes to guarantee efficiency and accuracy throughout the study
• Follow the Ockham Oncology global risk management process by adopting a risk-adapted approach
• Maintain a flexible, positive approach to address concerns innovatively and proactively

Risk-Adapted Approach

In order to meet all of the statutory requirements for the conduct of clinical trials, Ockham Oncology applies a range of risk adapted approaches. Ockham works collaboratively with clients to facilitate the agreement of all stakeholders on the level of risk associated with their clinical trial.

When addressing risk, our experienced Project Managers:

• Identify how risk-adapted approaches can be achieved within the current global regulatory framework
• Develop a risk-assessment tool on how to manage and conduct oncology clinical trials in a risk proportionate way
• Review categories of risk including, safety, legal and reputational risks, scientific and financial risks as well as the integrity of data and the reliability of results

Monitoring

Ockham Oncology is dedicated to employing and retaining experienced regionally based oncology Clinical Research Associates (CRA). These individuals are highly educated and dedicated professionals from diverse clinical backgrounds, including registered nurses, scientists, physicians and clinical specialists. Our goal is to ensure the highest quality review of data and effective interaction with study sites.

Ockham Oncology CRAs routinely:

• Oversee data collection
• Review source documentation and CRFs
• Ensure regulatory compliance
• Resolve data queries
• Conduct interim analyses as requested by clients

Risk-Adapted Trial Monitoring Plans

Ockham Oncology understands that clinical trial monitoring is not a standardized activity to be implemented uniformly across all trials. For each clinical trial, we develop a targeted and proportionate monitoring plan. We understand unanticipated risks may emerge in the course of a clinical trial and therefore we review and modify the risk assessment and associated monitoring plans as necessary.

At Ockham Oncology the extent and nature of monitoring is determined prior to the start of the clinical trial and is re-assessed during the course of the trial. The clinical trial risk assessment may be used to determine the intensity and the focus of the monitoring activity. The trial design would inform the methods used for monitoring and the assessment of the sites, staff facilities, and training needs may also influence the intensity and nature of monitoring methods.

Approaches depend on the nature of the risks identified for a clinical trial and their potential impact. Commonly used monitoring procedures include:

• Trial oversight structures – e.g., Independent Data Monitoring Committee (IDMC)
• Centralized monitoring activities including centralized data review, Web-enabled training, rates of recruitment, unusual data patterns, adverse event assessment, and CRF completion
• On-site monitoring visits

Within our Regulatory Affairs offerings we develop strategies, interpret regulations and provide guidance and address global regulatory submissions for compliance considerations. Regulatory Affairs will also provide support and preparation for meetings with regulatory agencies.

Development of Regulatory Strategies

• Preclinical through Phase IV programs

Interpretation of ICH, EU and FDA Regulations and Guidance

Global Regulatory Submissions

• Develop, write, compile, review regulatory documents for submission, including: CTA, IMPD, IND, IB, DSUR, NDA, BLA, MAA, ODD, PIP, etc.
• Review submissions for verification of compliance with applicable guidelines and for potential refusal-to-file issues
• Prepare and submit annual reports and maintain regulatory submissions

Provide Support for meetings with Regulatory Authorities

• Prepare briefing documents
• Attend meetings (Scientific Advice, pre- IND, etc.)
• Interact with regulatory authorities on behalf of clients

Scientific Affairs facilitates non-clinical and clinical development as well as medical writing expertise.

Non-Clinical Development

• Prepare non-clinical development plans
• Perform data reviews and gap analyses for development programs
• Oversee and execute non-clinical safety and pharmacology studies
• Write and/or review study protocols and reports, non-clinical sections for global regulatory submissions and Investigator Brochures

Clinical Development

• Prepare Clinical Development Plans

Medical Writing