Key Highlights
Delivering a Complex Phase I Clinical Pharmacology Study in Bulgaria
Clarenta supported an early-phase oncology study evaluating the pharmacokinetics and safety of an intravenous fixed-dose antiemetic combination in adult cancer patients receiving a single cycle of highly emetogenic chemotherapy.
Conducted at one external clinical research centre in Bulgaria, the Phase I study required intensive pharmacokinetic sampling, precise operational coordination and accelerated patient recruitment.
The Challenge:
The external clinical research centre had limited experience conducting Phase I studies and required additional early-phase expertise and resources to manage the study’s intensive clinical pharmacology procedures.
The study presented several operational challenges:
- Time-sensitive pharmacokinetic sampling required precise coordination
- Recruitment had to be completed within a compressed timeframe
- Study procedures needed to align with patients’ chemotherapy schedules
- The short participation period required rapid data collection, review and follow-up
- Samples had to be handled and processed according to defined timelines
Our Solution:
We implemented an integrated early-phase recruitment and site-support model.
- Provided experienced research nurses to support intensive pharmacokinetic sampling
- Assigned a dedicated site manager to coordinate the site team and study activities
- Provided on-site study-coordinator support
- Supported patient identification, screening and recruitment
- Coordinated sample handling and study logistics
- Supported timely eCRF data entry and query resolution
- Maintained the Investigator Site File
- Supported monitoring visits
- Maintained close communication among the investigator, site personnel and wider study team
The Outcome:
We supported the enrollment of 36 patients at one Bulgarian clinical research centre within approximately two months.
Our integrated operational model enabled the centre to manage intensive Phase I pharmacokinetic sampling and complete recruitment within the targeted period.