Preferred Partner for Advanced Pharmaceutical Research

SpinoS –Indian based clinical research organization which supports sponsors of pharmaceutical and medical device trials as well as other CROs in the following 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

SpinoS can offer a full CRO services which can be contracted individually or as a combined package based on the requirements of each specific clinical project.

Clinical Trial Planning

SpinoS has over a decade of experience in the planning and designing of translational studies and phase I-III clinical trials.

Our services include:

  • 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

Clinical Trial Management

Our trial managers have extensive experience in setting up, budgeting and conducting phase I through phase III clinical trials. 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.

Our services include:

  • 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 Trial Monitoring

SpinoS has specialized in the monitoring of clinical trials, Functioning as the key communication link between the sponsor and the clinical trial management team, our highly qualified and experienced clinical trial monitors provide excellent service.

Our services include:

  • 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 analyses
  • Investigational product accounting
  • Monitoring reports and follow-up letters

Clinical Site Management

The CRA is the key communication link between the sponsor and the clinical site and is responsible for assisting the site throughout the operative phase of the study to ensure that the trial site has the necessary information and support to conduct the trial according to 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 Trial Oversight

Our experienced clinical team performs quality oversight visits for CRO and pharmaceutical clients to review CRA and site performance, assess the qualification of investigators, inspect site documentation and examine drug accounting.

Clinical Trial Documentation

SpinoS documentation experts are able to assist the sponsor in the following areas.
SpinoS provides full study documentation support for its clients,
Our services include:

  • 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

Drug Supply Management

For each trial it is crucial that the investigational product is properly managed throughout its life cycle from release to destruction.
Our Pharmacist ensure that the IP has been manufactured and checked in accordance with internationally accepted standards of GMP for medicinal products for human use, track and guarantee the timely delivery of the IP at the investigational site(s) throughout the trial and assist the CRA and investigational site in all aspects of drug accountability.

Our services include:

  • 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

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.

Our services include:

  • 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

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.

Our services include:

  • 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

Full Service
Its mission is to combine a unique set of clinical research expertise to provide complete service solutions across all stages of the clinical development process from phase I to IV trials as well as retrospective studies. SpinoS can offers to its clients a full range of CRO service, from study setup and conduct, CRF design, data handling, analysis and reporting as well as all aspects of drug safety.

SpinoS offers its clients the following services:

Study Setup + Conduct

  • Scientific Consulting
  • Site Selection & Feasibility
  • Patient Recruitment
  • Regulatory Services & Provision of Legal Representative
  • Study Management
  • Study Monitoring
  • Study Documentation

Data Handling, Analysis + Reporting

  • Project Management
  • Data Management
  • Patient Recruitment
  • Biostatistics
  • Medical Writing
  • Proofreading & Translation

Drug Safety

  • Pharmacovigilance
  • Safety Writing

SpinoS services can be contracted as functional or full-service, based on each of our clients’ unique requirements