Preferred Partner for Advanced Pharmaceutical Research
SpinoS –Indian based Clinical Research Organization (CRO) that supports sponsors of pharmaceutical and medical device trials, as well as other CROs, in key areas of clinical research:
Clinical Trial Planning
SpinoS brings over a decade of experience in planning and designing translational studies and Phase I-IV Clinical Trials We offer comprehensive CRO services to ensure successful outcomes for our clients:
Our Process
SpinoS offers a full range of comprehensive CRO services that can be contracted individually or as part of a customized bundled package to meet the specific needs of each clinical project. As a full-service clinical research organization, we provide flexible solutions for clinical trials, bioequivalence studies, and regulatory compliance, ensuring we address the unique requirements of every client.
Spinos Life Science - Top CRO Full Services in India
SpinoS was established to create a comprehensive Clinical Research Organization (CRO), offering end-to-end services for Phase studies while ensuring systems and processes comply with global regulatory standards.
Clinical Trial Management
Our trial managers possess extensive expertise in setting up, budgeting, and conducting Phase I to Phase IV clinical trials for optimal results.
Clinical Trial Monitoring
SpinoS specializes in clinical trial monitoring, serving as the essential communication link between sponsors and clinical trial management teams. Our highly qualified and experienced clinical trial monitors provide exceptional service, ensuring comprehensive oversight, regulatory compliance, and data integrity management in clinical research:
Our Process
Over the years, we have developed excellent professional relationships with key thought leaders in common research indications such as oncology, cardiovascular disease and CNS. This has proven valuable to sponsors of clinical trials, especially in critical situations, when drawing on these relationships has helped spur recruitment, thus allowing important study timelines to be met
Spinos Life Science - Top CRO Full Services in India
SpinoS was established to create a comprehensive Clinical Research Organization (CRO), offering end-to-end services for Phase studies while ensuring systems and processes comply with global regulatory standards.
Clinical Site Management
The Clinical Research Associate (CRA) is a crucial communication link between the sponsor and the clinical site, providing essential support during the operational phase of the clinical study. They ensure that trial sites receive the necessary information and resources to conduct clinical trials in compliance with protocol specifications. Our services include:
Clinical Trial Oversight
Our experienced clinical team conducts quality oversight visits for CROs and pharmaceutical clients, reviewing Clinical Research Associate (CRA) and site performance. We assess investigator qualifications, inspect site documentation, and ensure drug accountability in clinical trials.
Clinical Trial Documentation
SpinoS documentation experts assist sponsors by providing comprehensive study documentation support. Our services include regulatory submissions, Trial Master File (TMF) management, protocol development, informed consent forms, and compliance documentation, ensuring successful clinical trials:
Our Process
Over the years, we have built strong professional relationships with key opinion leaders in critical research areas such as oncology, cardiovascular disease, and central nervous system (CNS) disorders. These partnerships are invaluable to sponsors of clinical trials, enhancing patient recruitment and ensuring that important study timelines are met.
Spinos Life Science - Top CRO Full servies in India
SpinoS was established to create a comprehensive Clinical Research Organization (CRO), offering end-to-end services for Phase studies while ensuring systems and processes comply with global regulatory standards.
Drug Supply Management
For each clinical trial, managing the investigational product (IP) throughout its entire life cycle—from release to destruction—is essential. Our pharmacists ensure that the IP is manufactured and verified in accordance with internationally recognized Good Manufacturing Practices (GMP) for medicinal products. They track and guarantee the timely delivery of the IP to investigational sites, assisting the Clinical Research Associate (CRA) and site staff in all aspects of drug accountability during the trial.
Our Process
Our pharmacists ensure that the investigational product (IP) is manufactured and validated according to internationally accepted Good Manufacturing Practices (GMP) for medicinal products for human use. They track and ensure timely delivery of the IP to investigational sites throughout the clinical trial and assist the Clinical Research Associate (CRA) and site staff in all aspects of drug accountability.
Bio-sample Management
The proper handling, shipment and tracking of biological samples plays a crucial role in many clinical trials. Our Bio-sample Management professionals are experts in this field.
Spinos Life Science - Top CRO Full Services in India
SpinoS was established to create a comprehensive Clinical Research Organization (CRO), offering end-to-end services for Phase studies while ensuring systems and processes comply with global regulatory standards.
Submissions to EC and Local Authorities
SpinoS has broad experience with the initial and subsequent submission of documents to ethics commissions as well as the registering and cancellation of investigational sites. With our detailed knowledge of all local regulatory and ethical requirements we can provide you the complete submission package or partial service.
Full Service
Its mission is to integrate a unique set of clinical research expertise to deliver comprehensive service solutions across all stages of the clinical development process, from Phase I to IV trials and retrospective studies. SpinoS offers clients a full range of CRO services, including study setup and conduct, Case Report Form (CRF) design, data management, analysis, reporting, and all aspects of drug safety. SpinoS provides the following services:
☆ Scientific Consulting
☆ Site Selection & Feasibility
☆ Patient Recruitment
☆ Regulatory Services & Provision of Legal Representative
☆ Study Management
☆ Study Monitoring
☆ Study Documentation
☆ Project Management
☆ Data Management
☆ Patient Recruitment
☆ Biostatistics
☆ Medical Writing
☆ Proofreading & Translation
☆ Pharmacovigilance
☆ Safety Writing