Pharma & Biotech

Oncostrata medical monitors and clinical development scientists are ready to effectively integrate and collaborate closely with your cross-functional teams, supporting your ongoing clinical development programs with our oncology and hematology expertise.

Clinical Development Expertise

Provide clearly articulated scientific explanations and presentations to multi-disciplinary teams and stakeholders

Medical data review support (e.g. prior to database snapshots or interim/final analysis)

CRO oversight

Contribution to submission documentation (e.g. Clinical Study Reports, Safety Narratives)

Clinical trial documentation authoring (e.g. Clinical Study Protocol, IB, ICF)

Review of Tables, Listings, and Figures

Assists in safety evaluation, trend assessment, and preparation for IDMC meetings

Scientific publication authoring assistance

Investigational New Drug Applications and Biologics License Applications

Clinical landscape evaluation and expansion into new disease areas

Literature review and competitive landscape

Anti-tumor efficacy assessments, indication-specific, for solid tumors and hematologic malignancies (examples: based on Lugano classification, RECIST 1.1, RANO, iwCLL, NCCN guidelines, etc.)

Our deep expertise in clinical development means we are ready to provide extensive support for your critical clinical trials, whether you are aiming for study design, regulatory submission or looking to find a partner for your program. As part of your Clinical Development team we are experienced and aim to support you across three critical aspects: data, documentation, and interactions.

Data

Study start up and database activities

Medical data review and coding

Review and Medical Monitoring of SAEs, AEs and AESIs (including treatment-associated toxicities)

Protocol deviation review and trend evaluation

Emergency database lock assistance

Biomarker review (e.g. genomic sequencing, tumor mutation burden, microsatellite stability)

Anti-tumor efficacy assessments, indication-specific, for solid tumors and hematologic malignancies (examples: based on Lugano classification, RECIST 1.1, RANO, iwCLL, NCCN guidelines, etc.)