Operations

Operations

Quality Assurance
All projects will be conducted within our GCLP Accredited laboratories (Good Clinical Laboratory Practice (GCLP) standard, 2011, ISBN 978-1-904610-00-7.) and in line with our policies and standard operating procedures. Synexa also incorporates the requirements of GCP (ICH E6), including the referenced requirements of GLP (OECD), however, Synexa has not been formally assessed according to these guidelines. Validations are performed according to the requirements of the applicable FDA guidance for industry and EMA guidelines. Synexa is committed to providing quality science that is reputable, trustworthy, and clinically relevant to our clients.
Study Management
Our team of study managers are qualified scientists with laboratory experience, excellent organisational and communication skills who are responsible for the complex task of keeping studies on track. Each study manager maintains frequent, high-quality communication between our clients, CROs and scientific teams and mitigating delays by timeously finding solutions. Our team has carried out numerous studies worldwide and are committed to achieving the desired outcomes of every study according to its scope and within the given time constraints.
Sample Management & Logistics
Synexa Life Sciences has a committed Sample Management & Logistics team that monitors and coordinates all sample and study-related logistics and procedures. In conjunction with the Study Management Team, the requirements for each study are identified, discussed and organized to ensure the appropriate packaging, transportation, sample/reagent integrity and temperature monitoring is adhered to. Synexa partners with reputable and experienced third-party global logistics specialists to fulfil all transportation needs. Our core focus is to optimize and ensure a smooth study workflow from conception to completion, ensuring the study plan, patient safety and result outcomes are prioritized throughout.
Global Operations Support
Our Global Operations team is key to supporting our customers around the world, and delivering reliable and trusted clinical trial services to our customers. The Operations team drives and facilitates long-term growth and value creation for the company. We are focused on excellence, ensuring high-quality scientific customer service delivery, relying on extensive experience and scientific judgment to plan and accomplish all deliverables.