Clinical Operations
Overcome your operational challenges
Clinical operations can slow your journey to market; Cytech’s expert team can optimize your clinical monitoring, manage vendors and improve efficiency to accelerate your process and reduce costs.
Our Services
Clinical Operations: Ensuring a Smoother Journey to Market
Embarking on a clinical trial is often fast-paced and fraught with unexpected risks that can delay progress and increase costs. Partnering with an expert who can swiftly and effectively address these challenges is essential for overcoming obstacles.
With robust support in clinical monitoring and operations, your trial gains stability and resilience, leading to greater efficiency, faster results, and a smoother journey to market. This ultimately benefits both you and the patients you serve.
Our clinical research associates (CRAs), lead clinical research associates (LCRAs), clinical trial assistants (CTAs), and project managers leverage their experience across all trial phases and therapeutic areas to help you successfully execute your trial and bring your intervention to market.
Cytech streamlines your clinical operations.
A dependable team of experts you can trust
A successful clinical trial is built on a clinical operations process executed with precision and integrity by a dependable and consistent team. At Cytech, we prioritize people. We support the long-term development of our talent pool, and our organization is designed to foster retention, providing you with the reassurance of a stable project team.
We recognize that clinical trials involve various stakeholders throughout the process. Our Clinical Operations team employs a flexible, people-centric approach that ensures effective collaboration, including with local and international key opinion leaders.
To maximize efficiency, we maintain short communication lines: our team works closely with Cytech’s pivotal operational departments, such as Medical Writing, Vendor Management, Regulatory Affairs, Data Management, and Pharmacovigilance. These strong connections allow us to deliver a trial that exceeds your expectations, quickly.
Clinical Monitoring Agility: Clearing the Hurdles for Your Clinical Trials
When conducting a clinical trial, your needs can evolve as the research progresses. To provide the best possible support, we utilize flexible monitoring strategies and tailor plans to meet the specific requirements of your trial. Our adaptable approach is data-driven, focusing on monitoring and data quality at the site level. We also leverage technology to enable smarter monitoring.
We start by establishing a detailed monitoring plan, including the level of Source Data Verification (SDV) and the monitoring processes we will follow. Depending on study requirements, site activity, and performance, we deploy flexible, data-driven monitoring strategies. This schedule can be adjusted based on factors such as recruitment and identified risks.
Cytech’s expert Clinical Research Associates (CRAs) follow the monitoring process to ensure sites adhere to the protocol, resolve queries, and close any pending action items. They concentrate on critical elements like data integrity, subject eligibility, protocol deviations, and data crucial to subject safety, study endpoints, and the reliability of findings.
Regular communication is integral to our approach. Our CRAs meet with investigators in person at the end of each visit to discuss findings and recommendations, such as retraining needs.
Our Services
Dependable CRAs for Your Clinical Monitoring Needs
Effective clinical operations demand both the extensive capabilities of a large team and the agility of a smaller, dynamic group. At Cytech, our optimal size allows us to handle both small and large-scale projects, providing the flexibility to adapt to your evolving needs.
Our scalable resourcing lets you tailor the support you need, whether it’s clinical monitoring with a single CRA or a comprehensive platform spanning multiple countries. Our flexible Resourcing, Functional Service, and Full-Service delivery options ensure we can bridge any operational gaps in your trial.
Streamlined Project Management to Accelerate Your Clinical Trials
Managing a clinical trial can be intricate, especially when coordinating across geographic areas and multiple teams. Cytech’s extensive team of expert project managers provides the capabilities you need for efficient project management.
With Cytech’s project management support, your operations can smoothly progress to the post-market stage. Our expertise spans every phase of clinical operations, from feasibility and study design to regulatory submission, vendor management, patient recruitment, and pharmacovigilance.
Our comprehensive services ensure your clinical operations run seamlessly from start to finish, including:
- Study and Country Feasibility: Our experts set you up for success from the beginning.
- Regulatory Submission and Local Ethics Committee/IRB Submission: Our teams leverage local expertise to navigate regulatory hurdles.
- Patient Recruitment: We assist in achieving your recruitment targets.
- Monitoring: We manage your clinical monitoring from site initiation to closure.
- Vendor Management: Cytech's vendor management expertise ensures a reliable supply chain.