Global Clinical Operations
Study design, endpoint selection, consultation with our Medical Experts Office. We can connect you with experts – over 20 years in clinical research means we’re connected.
We can provide a synopsis, review and expand yours, find experts to help out and write the formal protocol.
A wide array of pre-selected sites and trusted investigators throughout the world ranging from commercial sites, to high-speed academic, to specialized.
More than 20 years of experience contracting all aspects of clinical trial services. This often unanticipated source of delays needs to be managed.
IRB and EC submission
Whether at an experienced US site or a remote site in central Africa, we have experience, connections, and trained personnel to manage the site-EC/IRB interactions demonstrably improving efficiency.
Training and Site Initiation
Investigators and staff need up-to-date GCP training as well as training on the protocol. We track and provide all training with folks on the ground or remote via web-based training.
Our monitors follow internal and sponsor SOPs to provide complete monitoring of trial execution.
Oracle Clinical, Database Development, Maintenance & Discrepancy Management, CDISC Compliance, EDC compliant, fully customizable.
We develop and implement safety-monitoring plans for global execution and all phases of clinical trials.
Providing strategies and solutions to help sponsors maximize drug safety, we offer DSMB/SMC creation and management tailored to the needs of the protocol, the product, and the subjects.
Licensed and board-certified, in-house clinical research physicians supplemented with a network of physician consultants who provide specific therapeutic expertise.
We provide. Identify, and support access to a full range of laboratory services that are dedicated to clinical development. Key laboratories are located in key global regions, including the US, Singapore, India, China, and across Africa.
Investigational Product (IP) Management
Management of shipping, monitoring, storage, and disposal as well as import/export licensing in the US, Africa, South America, and other regions of the world.
Our team approach to quality management and compliance begins in the implementation phase and exists within all systems and processes throughout the lifecycle of a program or clinical trial. The approach includes the incorporation of standardization through a Quality Management Plan, staff education, written procedures, the establishment of defined metrics, and auditing.
We offer innovative clinical trial designs that take advantage of our in depth statistical expertise. Offering you cost effective, expert results for better decision making
Our wide range of support options provide economical solutions that positively impact your development pipeline.
Medical and regulatory documentation developed by experienced medical writing professionals.
We offer writing and communications services designed to manage the FDA relationship effectively, generate a rapport, identify pathways to maximize product success and avoid clinical hold.
eCTD compliant submissions to FDA
Submission and management of clinical trial applications across Africa and other non-US territories
Submissions management for IRBs and ECs
Non-Clinical, Manufacturing, and Laboratory Assays
We review your current data, plans for additional non-clinical studies and assays including (e.g., bioassay, PK/PD) and advise on adequacy to meet FDA standards, advise on improvements needed, if any, and deprioritize, where possible, studies not needed for FDA.
Clinical Development Plans
We provide expert-driven advice on a complete clinical development plan for therapeutics and vaccines. Validated through KOLs, plans can be concept sketches, synopses, or full protocols for Phase 1 and 2 studies sufficient to provide an initial indication of safety and efficacy.
We generate a fully-integrated product development timeline from pre-clinical through end of phase 2. This plan includes major milestones and interdependencies from start to finish allowing the most efficient plan to be executed and potential roadblocks to be identified.