Full trial design including statistical planning and sample size calculations.
Study Start Up
Feasibility, site selection, CTA and budget negotiation, PSV, SIV.
Regulatory and compliance framework with full document, TMF preparation and IRB management.
Vendor Identification and Engagement
Including vendors for lab, imaging, ECG, ePRO, EDC, IRT and more.
Document Creation and Management
Trial master file, protocols, IB, model ICF, data management Plan, monitoring plan, and more.
Our Featured Services
We can provide full-service clinical trial preparation support, or individual services to meet your needs. Our goal is to get your project started efficiently and effectively, laying the foundation for a successful clinical trial.
Protocol Design and Review
Our experienced medical writers and statisticians help design your trial and draft the protocol. If you already have a protocol, our therapeutic area, KOL review boards can provide feedback on inclusion and exclusion, as well as trial endpoints to facilitate adequate enrollment and valid data collection.
Trial Site Selection
We have deep connections with trial sites in the US, UK, Ireland, Europe, and Australia across many therapeutic areas. Let us choose the best sites for your trial, including appropriate patient populations and qualified investigators.
Streamlined Feasibility and Start-Up
We manage the feasibility and start-up process for you. Our experienced CRAs ensure rapid study start up, site management, and issue resolution, while communicating with you through the entire process.
Vendor Selection and Management
We can work with your favorite vendors or suggest our own trusted partners. We handle contracting, shipping and tracking oversight, training, and project management throughout the course of the trial.
IRB Management and TMF Creation
Our regulatory specialists will handle your IRB submissions, model ICF creation, and regulatory documents. We provide a template TMF including all documents required for trial start up and execution.
Featured Disease Areas
Alzheimer's disease clinical trials demand unique considerations due to the complex nature of the condition. Many AD clinical trials require patients to have specific genes or biomarkers for enrollment, and these patients can be difficult to identify and screen. Working with trial sites who maintain biometric databases increases enrollment exponentially. Individuals with Alzheimer’s are required to have a caregiver enroll in the trial and complete all visits with them.
Rigorous cognitive assessments, informed consent, and caregiver support are crucial. Flexible protocols and decentralized components help decrease the burden on caregivers. Additionally, specialized outcome measures, like cognitive and functional assessments, are required to gauge treatment efficacy accurately.
Ensuring a compassionate and supportive environment for participants and their families is paramount in Alzheimer's trials to navigate the emotional and cognitive challenges they face. Ethical and regulatory compliance, along with patient-centered care, are vital in conducting successful Alzheimer's clinical research. Working with a CRO who can provide these specialized clinical trial preparation services helps reduce risk and stress to increase the chances of a successful trial.
NASH Protocol Support
Our experts can help design protocols targeting recruitable populations, manageable inclusion criteria, and valid endpoints.
NASH Site Selection
We have connections to premium NASH trial sites, allowing optimal recruitment and successful trial completion.
Frequently Asked Questions
Planning for a clinical trial can be time consuming and overwhelming. Here are some questions Sponsors often ask about clinical trial preparation.
Preparing for a clinical trial? Engage a CRO for expert guidance. Discuss eligibility criteria, expectations for sites and investigators, regulatory strategy, budget, and expected endpoints.
Clinical trial planning is the meticulous process of strategizing and organizing every aspect of a study, from design to execution, ensuring precision and ethical adherence.
Clinical trial preparation and planning upfront is crucial for clinical trials to ensure efficient resource allocation, ethical considerations, and scientifically sound study design, ultimately enhancing the trial’s success and validity.
Common mistakes by pharmaceutical Sponsors include inadequate patient recruitment strategies, poor trial design, and under-estimating regulatory complexities, which can lead to delays and increased costs.