CLINICAL DEVELOPMENT, CLINICAL TRIAL DESIGN & IMPLEMENTATION
Drive your clinical trials to success with our comprehensive clinical development services.
From innovative trial designs to implementation, we ensure your studies are efficient.
CLINICAL DEVELOPMENT
Scientific review of clinical regulatory documentation
We help streamline the approval
process and reduce the risk of delays, ensuring your documentation is submission-ready
Advice and support for Clinical, Development Plan
We offer guidance and support to craft a Clinical Development Plan that is clean, cost-effective and aligned with your project’s needs
Drafting study synopsis; study protocol and investigator brochure
From outlining your study’s methodology to detailing essential information, we ensure that each document is align with scientific standards
Guidance on building the evidentiary basis for regulatory approval
Our team assists in studies that generate the critical evidence needed to meet regulatory requirements. We ensure that your submission is backed by effective information
Strategic guidance on clinical portfolio management
We help you prioritize and manage your clinical programs effectively, providing actionable insights to maximize the impact and efficiency of your clinical development efforts
CLINICAL TRIAL DESIGN
Trial design from early to late phase development
From early-phase feasibility studies to late-phase pivotal trials, our team ensures that your trial design is scientifically and strategically aligned with regulatory standards
Development of innovative clinical trial designs, study synopsis, study protocol
Our team designs and drafts
study synopses, protocols, investigator’s brochures, pharmacy and laboratory manual, and consent form tailored to your specific research objectives.
Selecting outcome measures
(clinical measures, PRO’s, biomarkers, digital sensors)
Our team helps identify and integrate clinical measures, patient-reported outcomes (PROs), biomarkers, and digital sensors that best capture the efficacy and safety of your intervention.
IMPLEMENTATION
CLINICAL TRIAL OPERATIONAL GUIDANCE
Selection of advisory boards, K O L s , sites and clinical operations team
Identification of high-quality clinical trial sites and opportunities & barriers to recruitment for clinical trials
Troubleshooting
Risk mitigation regarding
feasibility
