Clinical Development Strategy & Consulting
Development plans, regulatory strategy, protocol design and feasibility, worked out before a study starts.
Services
15 services in 5 groups. Hire us for a full program or for individual functions.
Some services are delivered with qualified partners under our oversight.
Strategy & Consulting
Regulatory & Medical
Regulatory affairs, medical writing, and physician-led medical monitoring and pharmacovigilance.
Regulatory Affairs
IND, CTA and IMPD dossiers; FDA, EMA and global health-authority submissions and meetings; clinical hold responses; import/export and ethics approvals.
Medical Writing
Protocols, Investigator's Brochures, informed consent forms, Clinical Study Reports and regulatory responses.
Medical Monitoring & Pharmacovigilance
Medical monitoring, SAE/SUSAR processing, IND safety reports, DSURs, signal management and DSMB/IDMC support.
Clinical Delivery
Clinical operations from global feasibility to close-out, cell & gene therapy trial support, site services and post-approval studies.
Clinical Operations
Global feasibility, site selection and start-up, risk-based monitoring, project management, TMF management and vendor oversight.
Cell & Gene Therapy Trial Support
Apheresis site qualification, chain of identity and custody, courier qualification and mock shipments, and long-term follow-up (LTFU) programs.
Site Services
Training, contracts, payments and quality support for investigator sites.
Post-Approval & Real-World Evidence
Long-term follow-up, registries, safety studies and real-world evidence after approval.
Data & Technology
Data management, biostatistics and programming, computer system validation, and clinical technology platforms.
Data Management
EDC build, data cleaning and coding.
Biostatistics & Programming
CDISC SDTM/ADaM datasets, define.xml and reviewer's guides; SAPs, interim and final analyses, and TLFs.
Computer System Validation & Data Integrity
Computer system validation and 21 CFR Part 11 compliance.
Clinical Technology Platforms
EDC, eTMF, CTMS, IRT, safety database and eConsent/ePRO implementation.
Quality & Compliance
Quality assurance and audits, inspection readiness, and quality management systems and SOPs.
Quality Assurance & Audits
GCP, vendor, TMF, GMP/GDP and CSV audits; quality agreements; CAPA and root-cause analysis.
Inspection Readiness & Support
Mock inspections, storyboards and interview preparation, live inspection support and Form 483 responses.
Quality Management Systems & SOPs
QMS design for sponsors and sites, SOP authoring and gap analysis, training and document control.
Let’s Advance Your Clinical Development Program
Planning a new trial, expanding an ongoing study or looking for specialized support? Talk to our leadership team about your goals.