CROs play a critical role in helping pharmaceutical companies conduct clinical trials efficiently, effectively, and in compliance with regulatory requirements. By providing expertise, resources, and infrastructure, CROs enable pharmaceutical companies to bring new drugs to market faster and more efficiently. CROs are responsible for managing various aspects of these trials, including study design, patient recruitment and retention, site selection and management, data management and analysis, regulatory compliance, and medical writing and reporting. This is where companies like SanaClis come in. SanaClis is a full-service Global CRO and one of the very few service providers with a broad range of internal clinical supply chain, logistics, and sourcing skills. The company provides a full range of end-to-end solutions for clinical trials worldwide throughout the entire life cycle of the study. SanaClis may serve as a full-fledged service provider by adapting to the demands of the sponsor. SanaClis has a wealth of expertise managing clinical trial projects effectively for sponsors of all sizes, from top 10 pharmaceutical firms to virtual biotech businesses. Every project committed to care is completed ahead of schedule or on schedule and always completed within the allocated budget, assuring quality, competence, and responsiveness.

SanaClis offers a wide variety of CRO and clinical supply chain services in all therapeutic areas and global locations (the entirety of Europe, the United Kingdom, Asia, and the USA). Its extensive and distinctive clinical expertise in CEE nations also provides a wealth of benefits, from high patient participation rates to high-quality data. In addition, SanaClis offers a network of independently owned, well-located storage and delivery facilities that are GMP and GDP certified. These cutting-edge facilities provide enough storage capacity at all necessary temperatures as well as the associated Clinical Supply services required throughout the IMP’s cold chain life cycle. SanaClis has completed several clinical studies (innovative, biologics, biosimilars, and generics), proof-of-concept, and medical device projects. It has a rich collection of detailed SOPs to make sure all staff members are effective, maintain high-quality output, and work consistently. This eliminates the chance of misconceptions and noncompliance with industry requirements. Every action is taken strictly by the relevant procedures. SanaClis is a full-service Global CRO with an end-to-end array of in-house clinical supply chain services, logistics, and sourcing skills.

All SOPs are also thoroughly reviewed regularly to ensure that they are systematic and appropriate, and they are amended as necessary both internally and by the sponsor. Another service offered by SanaClis is Regulatory services which is still a top choice for any local or international regulations that are pertinent to the undertaking. Renowned regulatory experts who have previously held top board positions within international regulatory agencies like the EMA and FDA make up and manage regulatory departments.  The specialized regulatory team closely collaborates with each sponsor to ensure complete adherence to local and regional regulatory requirements. This includes providing professional advice on all supply chain regulatory matters, such as local labeling standards. Clinical trial regulation and regulatory-scientific issues are continuously evolving, mainly as a result of several legislation and numerous new guidelines that have been enacted by various regulatory authorities.

The SanaClis Regulatory division manages the filing of Clinical Trial Applications to Regulatory Authorities, Ethic Committees, and other pertinent official organizations that may be involved in approving experimental pharmaceutical products and medical devices. This includes the original clinical trial applications (CTA) and any additional life-cycle submissions necessary to keep the CTA current, such as updates, notifications, and clinical study reports. Regular interaction and communication with the RA/EC are usual throughout the Clinical Trial. “At sanaClis, is dedicated to delivering innovative solutions for the healthcare industry that improve quality, reduce costs, and enhance the patient experience. “At sanaClis, we are dedicated to delivering innovative solutions for the healthcare industry that improve quality, reduce costs, and enhance the patient experience. Our expertise in information technology and digital health has enabled us to become a trusted partner for organizations seeking to transform their operations and drive better outcomes,” says Alexander Fetkovsky, CEO, SanaClis.

The future of SanaClis looks bright, with a growing demand for their services as the pharmaceutical and biotech industries continue to expand. Clinical research organizations have a unique role in the healthcare industry. They are responsible for conducting clinical trials, collecting data, and analyzing it to develop new treatments and drugs. As technology advances and more data becomes available, the scope of clinical research is expected to expand substantially.