Services

e-Source Study Design and Maintenance

Koncord Clinical Research Services offers a comprehensive suite of e-Source and paper source template design services, data migration support, and protocol amendment execution. We ensure that your study’s data collection process is efficient, compliant, and seamlessly integrated with your CTMS platform, whether electronic or paper-based. By leveraging our expertise with systems like CRIO, Real-Time, and other CTMS platforms, we guarantee the highest levels of data integrity, regulatory compliance, and operational efficiency throughout the lifecycle of your clinical trial.

e-Regulatory Services

Our team of professionals provide comprehensive support to help you set up and maintain electronic binders (eISF), ensuring up-to-date documentation and full regulatory compliance. We assist with Paper to electronic migration of regulatory binders in CTMS, assist with Study Start-up, Monitoring, and Close-out Responsibilities, handle IRB submissions as defined by the Local or Central Ethic Committees and Regulatory Authorities, appropriate reporting of protocol deviations and AE/SAE reporting, provide ongoing support to trial sites through audit and regulatory inspections to maintain compliance.

Research Finance and Budget/ Contracting Services

At Koncord, we map the budget with the protocol to verify and incorporate any additional procedures or assessments if necessary. We calculate procedural costs and study-related expenses using the Fair Market Value of Procedures to summarise the percentage margin earned. Additionally, we help recover revenue from trial activities by conducting a thorough financial audit for payment dues by comparing source data and study budgets before study closeout. We also assist with budget negotiation, configuring the budget in the sites’ CTMS system, performtimely invoicing and keep up with budget amendments.

Business Development (Feasibility)

Our Feasibility team provides an inclusive evaluation of site and investigator profiles with a data-driven approach to site evaluation, ensuring that every study is conducted at sites with the right capabilities, infrastructure, and patient pool. Our thorough assessments improve site performance, expedite study startup, and optimize recruitment and retention, leading to successful trial outcomes and maximizing study revenue.

Pre-screening and Enrollment

Our recruitment planning and patient engagement strategy is designed to optimize enrolment, improve diversity, and enhance participant quality. Byleveraging advanced data tools, managing inbound leads effectively, and employing targeted community outreach, we ensure that clinical trials are populated with the right participants while reducing recruitment timelines and maximizing study success.

Site Operations

Ouroperations team serve as catalysts for smooth and efficient trial execution by providing ongoing support through electronic data capture systems (EDC) within a 24-hour timeline to facilitate data integrity and support timely study completion.Our highly trained professionals verify Informed consent forms (ICFs), prepare for Interim Monitoring Visit (IMVs), assess Eligibility, ensure Investigational Product (IP) dosing and visit compliance and conduct data quality checks to ensure compliance without compromising on the quality at trial sites.