Mail

info@biowebclinical.com

Our Services

Timelines for start-up & Regulatory activities:

LEC approval – up to 4 weeks

RA approval –21 working day for review+15 working days for queries answering

Contract negotiation with sites up to 3 month 

Clinical Operations

We conduct detailed feasibility assessments to determine the most effective approach for your clinical trial, including patient population analysis, site capabilities, and regulatory pathways.

Our site selection process identifies high-performing sites based on experience, enrollment potential, infrastructure, and past performance, ensuring optimal study execution.

We offer both on-site and remote clinical monitoring services to ensure subject safety, data integrity, and GCP compliance throughout the trial.

Regulatory Affairs

We manage all aspects of site initiation—from document collection and Local Ethics Committee and Regulatory Authority submission to site activation—ensuring a streamlined and timely start.

Our regulatory experts support submissions at Local Ethics Committees and Regulatory Authority ​, ensuring compliance with current legislation and guidelines.

We offer expert legal and regulatory review of study-related documents to ensure clarity, compliance, and enforceability.

Clinical Laboratory

We can provide the service of procurement, storage, and distribution of medical supplies, including sourcing custom items based on specific study requirements.

We offer full-service clinical laboratory support, including acting as a Central Laboratory for your study. Our services cover sample processing, analysis, and result reporting with high standards of quality and turnaround 

We can coordinate all aspects of transportation for study materials, biological samples, and investigational products, ensuring safe and timely delivery.

Contract & Budget Negotiation

We handle contract negotiations and budget development with sites and vendors, ensuring favorable terms and cost-effective operations.

Other

Our team provides oversight and coordination, ensuring your study stays on track, on time, and on budget.

We provide certified translation of study documents, patient-facing materials, and regulatory submissions in multiple languages.

Our CRO can support with the customs clearance services for Import and Export of the trial related goods.