Clinical trials are an important part of the drug development process as they help evaluate the safety and efficacy of new medical treatments, devices, diagnostic tests and vaccines. Conducting clinical trials efficiently requires extensive expertise and support services from experienced clinical research organizations (CROs). This article discusses some of the key clinical trials support services offered by CROs that help pharmaceutical and biotech companies smoothly run their clinical studies.

Regulatory Support

One of the most Clinical Trials Support Services functions provided by CROs is regulatory services. Navigating the complex regulatory approvals process to obtain permissions to initiate clinical trials can be highly challenging for sponsors without deep regulatory expertise. Experienced CRO regulatory teams understand global regulatory guidelines, have relationships with regulatory agencies worldwide and can efficiently shepherd sponsors through regulatory submissions. Their regulatory knowledge allows sponsors to stay compliant with regulations throughout the clinical trial process. CROs help draft protocols, clinical study reports, investigator brochures and other key documents required for regulatory submissions. They also facilitate pre-submission meetings with regulators and submit applications to ethics committees and regulatory agencies on sponsors’ behalf to obtain the necessary approvals to start patient recruitment and dosing.

Clinical Operations Management

Setting up clinical operations at multiple sites across different countries is a massive undertaking that requires skilled project management. CROs take care of the entire clinical operations aspect, from site and investigator identification and selection to site initiation, oversight and closeout. Their experienced clinical operations teams will handle logistics related to site contracts, payments, supplies, document management systems, clinical trial management software and IT/data management infrastructure. CROs oversee site qualification, training, monitoring visits and ensure protocol compliance. Their project managers track timelines, budgets, deliverables and maintain regular communication with sites and the sponsor. This allows sponsors to focus on their core responsibilities while leveraging the economies of scale that CROs offer through their established global infrastructure and processes.

Data Management and Biostatistics

Data integrity and quality are of paramount importance in clinical research. CROs employ certified data managers, medical coders and biostatisticians to provide end-to-end data management and biostatistical services. They design clinical databases and eCRFs, train site staff on data collection, perform source data verification, and ensure accurate capture and processing of study data. Experienced biostatisticians jointly work with sponsors on the clinical trial design, sample size calculation, randomization strategies and statistical analysis plans. At the analysis stage, they generate tables, listings, graphs and clinical study reports, and perform intermediate analyses to enable ongoing safety monitoring and assessment of efficacy endpoints. Biostatisticians also facilitate regulatory statistic reviews and scientific advice procedures. Overall, CRO data and biostatistics teams ensure sponsors adhere to data handling best practices and gain valuable insights from their studies.

Medical Monitoring and Safety Reporting

Ensuring patient safety is the top priority in clinical research. Clinical Trials Support Services medical monitors systematically review safety data from sites to identify, evaluate and report adverse events promptly to sponsors, ethics committees and regulators. They conduct source data review, resolve data queries, oversee drug accountability and maintain investigator site files. Experienced CRO medical teams utilize cutting-edge safety management platforms for signal detection, aggregate reporting and risk minimization action planning. Moreover, CRO medical experts draft safety sections of clinical documents such as investigator brochures and development safety update reports while liaising with sponsors on risk-benefit assessment. Their involvement helps minimize safety concerns during trials and supports expeditious safety reporting.

eClinical Solutions

With technology significantly enhancing clinical research capabilities, many CROs offer end-to-end eClinical solutions powered by tailored software suites. These range from electronic data capture, clinical trial management solutions and interactive response systems to EDC, CTMS, IWRS etc. CRO eClinical teams optimize platform selection, implement custom builds, transfer legacy data, configure electronic patient-reported outcomes and overall improve study efficiency. Their integration with other CRO service lines allows for a fully digital clinical trial experience encompassing protocol design, site selection and centralized monitoring using a technology backbone. Combined with robust data security, eClinical platforms streamline data-driven decision making for sponsors, particularly amid distributed and virtual clinical trial models ushered in by the ongoing pandemic.

outsourcing clinical trials to qualified CROs allows biopharma companies to access comprehensive expertise and globally scalable capabilities for all aspects of clinical research. From protocol design to site operations, data collection, monitoring, analytics and reporting – experienced CROs deliver integrated, quality services and solutions that optimize resource utilization and reduce sponsor workloads. Leveraging specialized CRO support enables sponsors to stay focused on core innovation and accelerate candidate progress through development milestones to commercialization. Use of multiple CRO service offerings helps deliver clinical trials more efficiently, with higher compliance and oversight standards thereby strengthening overall development programs

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1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it