1. Sponsor Information
2. Service Areas of Interest (select all that apply)
Clinical Trial Services (Phase I–IV) Drug Discovery & Development Bioavailability / Bioequivalence (BA/BE) Studies Central Laboratory Services (Diagnostics, Genomics, Bioanalytics) Quality Assurance & Compliance Market Access & Health Economics Real-World Evidence (RWE) & Data Analytics Pharmacovigilance & Medical Monitoring Site Network & Feasibility Support Others
3. Study / Project Overview
4. Scope of Work Requested: Please outline the specific tasks or services required from Xcene Research.
Clinical Trial Services
Project Management Regulatory Affairs Services Study Start-Up & Feasibility Site Selection & Activation Monitoring (On-Site / Remote / RBM) Data Management & Biostatistics Quality Assurance & Auditing Pharmacovigilance / Safety Reporting Laboratory Management Medical Monitoring Data Privacy & Data Protection Compliance Quality Assurance & Compliance Clinical Supplies & Logistics Consulting & Strategic Advisory Drug Depot Management
Drug Discovery & Translational Research
Target Identification & Validation Hit-to-Lead & Lead Optimization Preclinical Studies (Pharmacology, Toxicology, PK/PD) Translational Research / Biomarker Development
Bioavailability / Bioequivalence (BA/BE) Studies
Study Design & Protocol Development Clinical Phase (Dosing, Sample Collection & Volunteer Management) Bioanalytical Method Development & Validation Pharmacokinetic (PK) / Pharmacodynamic (PD) Analysis Statistical Analysis & Reporting Regulatory Submission Support (NAFDAC, EMA, FDA)
Central Laboratory Services (Diagnostics, Genomics, Bioanalytics)
Diagnostic Testing (Hematology, Chemistry, Immunology, Microbiology) Genomic & Molecular Research (NGS, PCR, Gene Expression) Biomarker Discovery & Validation Bioanalytical Testing (LC-MS/MS, HPLC, ELISA) Sample Logistics & Kit Management Data Management & LIMS Integration
Market Access & Health Economics
Pricing & Reimbursement Strategy Health Technology Assessment (HTA) Support Payer Engagement / Policy Advisory Cost-Effectiveness Modeling / Budget Impact Analysis Real-World Evidence (RWE) Observational Study Design Registry or Database Development Retrospective / Prospective Data Analysis
RWE Publication Support
Observational Study Design Registry or Database Development Retrospective / Prospective Data Analysis RWE Publication Support
Please provide any additional context or specific deliverables required:
5. Regulatory & Compliance Information
Has the study been approved by a regulatory authority (e.g., NAFDAC, EMA, FDA)?
Yes No
Data Protection Requirements (NDPR, GDPR, etc.)
Yes No
6. Budget & Timelines
7. Supporting Information
Protocol / Synopsis Investigator Brochure (IB) Laboratory Manual / Specifications Confidentiality Disclosure Agreement (CDA) Draft RFP Scope Document Feasibility Questionnaire Budget Template Other
8. Upload file
9. Additional Notes or Comments