Global Clinical Operations

Our innovative, performance-driven approach and resources can ensure that your studies yield high quality data within strict timelines and budget requirements.

Protocol Development

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.

Site Selection

A wide array of pre-selected sites and trusted investigators throughout the world ranging from commercial sites, to high-speed academic, to specialized.

Contracting

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.

Clinical Monitoring

Our monitors follow internal and sponsor SOPs to provide complete monitoring of trial execution.

Data Management

Oracle Clinical, Database Development, Maintenance & Discrepancy Management, CDISC Compliance, EDC compliant, fully customizable.

Pharmacovigilance

We develop and implement safety-monitoring plans for global execution and all phases of clinical trials.

DSMB/SMC

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.

Medical Monitoring

Licensed and board-certified, in-house clinical research physicians supplemented with a network of physician consultants who provide specific therapeutic expertise.

Laboratory Services

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.

Quality Assurance

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.

Biostatistics

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 Writing

Medical and regulatory documentation developed by experienced medical writing professionals.

Regulatory Strategy

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.

Regulatory Operations

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.

Timeline Management

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.

 

GENERAL INQUIRY
Corporate Headquarters
800.431.9640
330.278.2343
info@clinicalrm.comFederal Services Operations
301.620.1987
info@clinicalrm.comInternational Operations
800.431.9640
info@clinicalrm.com

 

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