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Our Expertise
Clinical Study Development Planning
Development of end-to-end clinical strategies tailored to product type, target market, and regulatory expectations. This includes identifying required studies, timelines, and critical milestones.
Protocol Review & Regulatory Oversight Support
We offer strategic assistance in reviewing clinical trial protocols and ensuring alignment with regulatory requirements. Our support helps sponsors and teams navigate complex compliance landscapes for both drug and device studies, enhancing the quality and success of regulatory submissions.
ProConXol offers integrated clinical development services to accelerate trials and ensure global regulatory compliance. Solutions include clinical strategy planning, protocol review, CRO coordination, and end-to-end trial management. Additional services cover IRB submissions, GCP-compliant training, data management, and virtual regulatory staffing. ProConXol also supports building internal clinical teams with recruitment and SOP development—empowering long-term trial success.
Coordination with CROs and Consultants
Oversight and coordination with CROs and third-party consultants to ensure alignment with trial objectives, timelines, and regulatory requirements.
Investigator and Site Training
Development and delivery of training materials and sessions to ensure protocol compliance, adherence to GCP, and accurate data collection.
Clinical Trial Management Support
We provide expert support across the full lifecycle of clinical trials. From site startup to study closeout, our team assists with key aspects such as site monitoring, compliance tracking, issue resolution, and more—empowering your team to manage trials effectively while ensuring regulatory standards are met.
Management of IRB Submissions & Clinical Documentation
Preparation, review, and submission of IRB/ethics committee documents, including protocols, ICFs, safety reports, and amendments.
Virtual Regulatory Staffing Support
Provision of experienced, flexible regulatory professionals to support clinical trials during high-demand periods or specialized project needs. Virtual staff can assist with critical tasks such as regulatory filings, protocol development, documentation preparation, compliance reviews, and ensuring alignment with regulatory requirements. This service allows for scalable support without the need for permanent hiring, offering a cost-effective solution for maintaining compliance and meeting project timelines.
Clinical Data Management
Implementation of validated data capture systems, query resolution, data cleaning, and database lock, compliant with 21 CFR Part 11.
Assistance to Build an Internal Clinical Team
Support for the development and recruitment of an internal clinical trial team, from identifying key roles to assisting with hiring strategies, job descriptions, and team integration. Additionally, help with the creation of clinical trial Standard Operating Procedures (SOPs) and relevant forms, ensuring that the internal team is equipped with the necessary frameworks and documentation for smooth trial execution. This service ensures that companies have a robust internal clinical team in place to manage ongoing trials and future clinical projects effectively.