Regulatory Compliance Services

Precision Oncology works with sponsors and sites to prepare for regulatory agency audits. The key to the success of any product is ensuring that the clinical trials and development programs withstand the rigor of an independent inspection. We provide sponsors with an impartial assessment to ensure compliance with the protocol, Standard Operating Procedures (SOPs), and regulatory guidelines necessary to verify the safety of study participants and the integrity and validity of study data. Quality and regulatory compliance assessments include various types of audits at multiple stages throughout a clinical development program. These assessments are necessary to ensure early detection of potential issues and allow for timely intervention and implementation of appropriate corrective actions without compromising data quality.

Precision Oncology provides:

• Training in the areas of Good Clinical Practice /International Conference on Harmonization (GCP/ICH)

• Support for clinical site preparations for Regulatory Inspection

• Investigator Site Audits

• Mock FDA sponsor Inspections

• Hosting of sponsor Audits and Regulatory Inspections

• Performing GAP assessment in preparation for Audit and Regulatory Inspections

• Internal system audits of operational processes

• Standard Operating Procedure (SOP) development and oversight

• Vendor Qualification Audits ( Pre-selection)

• Ongoing quality audits to assess vendor adherence to contract responsibilities

IND/NDA Submission Consulting

Precision Oncology staff has significant experience with all stages of drug development, from pre-IND meetings and IND submissions to end-of-Phase II meetings, pre-NDA/MAA meetings and NDA/MAA submissions. We support strategic discussions leading to IND development and project management through the entire submission process.

• Assistance with pre-IND Meetings

• IND Compilation and Submission

• IND Maintenance

• IND Amendments

Precision Oncology’s NDA submission experience includes substantial eCTD formatted submissions. We assist in operational strategy, implementation and project management for the development and submission of electronic marketing applications.

• Assist with pre-NDA/MAA Meetings

• NDA/MAA Development Strategy

• Project Manage the cross functional compilation of NDA/MAA

• Manage submission vendors

• NDA/MAA submission consistency and quality control reviews