Immune System in Drug Development
Synexa works according to the international guidelines for clinical studies. All work is conducted in line with the policies and standard operating procedures (SOP) of Synexa Life Sciences. Synexa holds ISO 15189 accreditation, with these management requirements applied to the entire company. Synexa incorporates the requirements of GCP (ICH E6), including the referenced requirements of GLP (OECD), and follows the WHO guideline on GCLP. Synexa has not, however, been formally assessed according to these guidelines. Assay validations are performed according to the requirements of the applicable US Federal Drug Administration (FDA) guidance for industry and European Medicines Agency (EMA) guidelines.
Our 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, Contract Research Organizations (CROs) and scientific teams, mitigating delays and rectifying problems. As the main point of contact, this team is committed to achieving the desired outcome of every study according to its scope and within the given time constraints. The study management team looks forward to collaborating with you.
During the course of a study, important logistical procedures are managed and monitored by a dedicated logistics management team. In consultation with the study management team, the requirements for each study are discussed and organized to ensure appropriate transport, stability and temperature monitoring of all samples and reagents. We partner with reputable and experienced third party global logistics specialists to fulfil our transportation needs. Our focus is to optimise workflow from study inception to completion.
Security & Privacy
Security & Privacy
Our goal is simple: prevent unauthorized access and protect private data. Synexa goes the extra mile to ensure all IT systems and company assets – computers, networks and data – are fully secured and encrypted to block access to unauthorized users and/or hackers. We strive to maintain the integrity of our systems and confidentiality of sensitive information and data. As the cyber security industry evolves, we implement the latest, industry-leading hardware and software to mitigate risks and to protect your data.
Synexa has adopted the latest IT systems to ensure that our platforms use the most effective and efficient technology and processes to achieve our goals. This allows us to combine and implement policies and processes to ensure IT systems are aligned with our organizational needs and requirements.
Our hardware and equipment is sourced from industry powerhouses to ensure our systems remain consistent, functional, reliable, sustainable and current.
We have designed a global Synexa network that crosses borders and seas to ensure a virtual network across all our sites. Our networks are fully end-to-end encrypted to ensure the secure transfer of all company and client data.
Each of our facilities is maintained to the highest standards. Our laboratories were established according to the company’s standard operating procedures (SOPs), which comply with international quality guidelines. All equipment is qualified for service prior to use in any study. Our laboratories and temperature-sensitive equipment are temperature regulated with back-up power supply in the event of power loss.
Our finance team ensures seamless transactions and provides guidance in all financial aspects of our logistics, study management and business development teams. This ensures that each project moves smoothly through each stage, from initial consultation to completion.