Clinical Trial Management

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
  • Clinical Trial Management
  • Clinical Trial Monitoring
  • Clinical Site Management
  • Clinical Trial Oversight
  • Clinical Trial Documentation
  • Trial Master File Management
  • Drug Supply Management
  • Bio-sample Management
  • Submissions to EC and Local Authorities
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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:

  • Study concept, planning and set-up
  • Site feasibility and site selection
  • TMF set-up
  • Consulting on (e)CRF selection and design
  • Organization / leading of investigator meetings
  • Creation of study documents and study specific operation guides

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.

  • Oversight of study conduct and study monitoring
  • Budget management and tracking
  • Coordination of the study team
  • Oversight of quality and timelines
  • Risk assessment
  • Vendor management
  • On-site safety (AE / SAE/ medical incidents) management
  • Investigational product management
  • Clinical study report and review
Clinical Research Studies
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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:

  • Full monitoring-services, on-site and remote
  • Site visits (selection, initiation, interim, close-out)
  • Source data verification
  • Check of study lists and documents
  • ISF set-up and maintenance
  • Training of site staff
  • Monitoring compliance with ICH-GCP, study protocol and regulatory requirements
  • Conduct of interim analysis
  • Investigational product accounting
  • Monitoring reports and follow-up letters

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:

  • Preparation of site specific documentation
  • Training of site staff
  • Remote AE / SAE management
  • Remote query management
  • Follow-up related to monitor visits
Clinical Research Organization

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 Research Studies

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:

  • TMF set-up
  • ISF set-up and shipment to sites
  • Consultation on CRF selection and design
  • Design of study documents (logs, worksheets, manuals, guidelines, tracking lists)
  • Trial Master File Management

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.

  • Ensuring the timely supply and availability of the investigational product at the investigational sites
  • Tracking of the investigational product from delivery to destruction
  • Tracking of validity and expiration of the investigational product
  • Providing support to study management and CRAs regarding drug accountability
  • Creation of labeling and packaging according to medicine laws and international guidelines
  • Creation of documentation related to investigational product
  • Providing training to the study team and clinical site team regarding the handling of the investigational product
Clinical Trial Management

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.

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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.

  • Planning, organization and oversight related to the collection, processing and logistics of biomarker and pharmacokinetic samples
  • Creation of the Biosample Management Plan, lab manuals, sample handling sheets, etc.
  • Development of the sample logistics plan and the requirements for the collection of and storage of Bio and PK samples in close cooperation with central labs and other vendors
  • Ensuring that Bio and PK samples are taken and processed according to the clinical protocol, SOPs and ICH-GCP guidelines
  • Reviewing the suitability of investigational sites to collect, process and ship Bio and PK samples
  • Training of the study team and clinical sites regarding the collection and processing of Bio and PK samples

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.

  • Clinical trial applications
  • Collection of all relevant documents
  • Submission package to ethics committees for study approval
  • Submission of updated documents or changes to ethics committees
  • Correspondence with local regulatory authorities and ethics committees
  • Registration and cancellation of investigational sites with local authorities
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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

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Clinical Research and Clinical Trials
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