Malignant neoplasm

Case Study: Olaparib Pharmacokinetic / Bioequivalence Study

Therapeutic Area:

Oncology – Solid Tumors

Study Type:

Pharmacokinetic (PK) / Bioequivalence Study (BE) | Full-Service CRO Support

Background:

Olaparib is an innovative oncology therapy under development. Smooth Drug Development supported a pharmacokinetic and bioequivalence clinical study designed to evaluate drug bioequivalence under fed and fasting conditions in patients with malignant neoplasms of various localizations.

Study Design & Population:

The study was conducted in patients with malignant tumors of various localizations after multiple administrations of each study drug under fasting conditions and after food intake.

• Multicenter design

• Study duration: 9 months

• 28 approved clinical sites

• 16 activated sites

• 12 actively enrolling sites

• 4 backup sites activated to mitigate the risk of slow enrollment

• 72 enrolled subjects

Most study sites were located in remote regions, as large urban centers required significantly higher PI and site grants. Under a limited project budget, Smooth Drug Development strategically selected remote sites that did not request high grants and demonstrated strong patient access and high enrollment performance.

Scope of Smooth Drug Development Services:

Smooth Drug Development managed the full clinical trial lifecycle, including:

• Site initiation and monitoring

• Training of site personnel

• Logistics and supply management

• PK sample handling oversight

• Quality and compliance management

PK Study-Specific Challenges:

As a pharmacokinetic study, the trial required a high level of operational precision and preparation:

• Strict control of standard meals to ensure protocol-compliant fed/fasted conditions

• Comprehensive training of site personnel on PK blood sample collection, processing, storage, and shipment

• Coordination to ensure temperature-controlled storage and timely transfer of PK samples

• Alignment of procedures across all participating sites

Smooth Drug Development Full-Service Solution:

• Developed and implemented standardized meal plans across sites

• Conducted targeted training sessions focused on PK sample handling and storage requirements

• Provided continuous monitoring and operational support to ensure protocol adherence

• Ensured uninterrupted logistics and timely delivery of trial materials

Results & Outcomes:

• Successful completion of the PK/BE study across all 16 sites

• All 72 subjects enrolled and evaluated per protocol

• High-quality PK data generated under fed and fasting conditions

• No delays related to logistics or sample handling

• Full regulatory and GCP compliance maintained

Impact:

This study demonstrated Smooth Drug Development’s expertise in managing complex PK and bioequivalence studies in oncology populations, including precise operational planning, strategic site selection under budget constraints, remote site activation, rigorous staff training, and strict operational control of study conditions.