Clinical Trial Supplies Management 
Establishing Firm Grounds for your Products
As biopharmaceutical companies expand their operations, the various components of the trial see variations as per the local regulations and infrastructure. One of the key drivers of a safe clinical trial is the supply chain management for the drug that is being administered. Given that factors like temperature sensitivity, regulatory compliance, safety and security of the drug has huge impacts on timelines and costs of a study, sponsors and CROs have realized the need to focus on Clinical Trial Supply Management.
SIRO Clinpharm is one of the few clinical research organizations in the Indian sub-continent to offer clinical trial supplies (CTS) management services. Our fully equipped CTS facility is located in Mumbai and is well connected to all parts of the country. We offer end-to-end supply solutions, from drug importation to shipment to hospital sites.
SIRO CTS Facility
Keeping in mind today's stringent regulatory needs, we have put in place comprehensive SOPs and work documents for compliance with GCP, GMP, GDP and GSP norms. Our facility is equipped to maintain different temperature zones with a separate quarantine section. Round the clock temperature monitoring and adequate power back-up ensure that the temperature is always maintained within limits. We understand and maintain confidentiality for all our client's products.
Key services include:
Why SIRO Clinpharm?
Over the past 10 years, we have worked with several large and small biopharmaceutical companies and have successfully executed close to 300 projects. Our SOPs and work practices which are compliant to ICH-GCP guidelines ensure high quality deliverables with reduced error rates. We have successfully passed several government and sponsor audits which is a testimony to our high standards of quality.
Some of our other services include medical writing which will assist in getting your research published, as well as clinical data management.
For more information email us at bd@siroclinpharm.com or contact us today.
As biopharmaceutical companies expand their operations, the various components of the trial see variations as per the local regulations and infrastructure. One of the key drivers of a safe clinical trial is the supply chain management for the drug that is being administered. Given that factors like temperature sensitivity, regulatory compliance, safety and security of the drug has huge impacts on timelines and costs of a study, sponsors and CROs have realized the need to focus on Clinical Trial Supply Management.
SIRO Clinpharm is one of the few clinical research organizations in the Indian sub-continent to offer clinical trial supplies (CTS) management services. Our fully equipped CTS facility is located in Mumbai and is well connected to all parts of the country. We offer end-to-end supply solutions, from drug importation to shipment to hospital sites.
SIRO CTS Facility
Keeping in mind today's stringent regulatory needs, we have put in place comprehensive SOPs and work documents for compliance with GCP, GMP, GDP and GSP norms. Our facility is equipped to maintain different temperature zones with a separate quarantine section. Round the clock temperature monitoring and adequate power back-up ensure that the temperature is always maintained within limits. We understand and maintain confidentiality for all our client's products.
Key services include:
- Storage of investigational products and ancillary supplies
- Storage of non-IP study materials
- Returns and IP destruction
- Relabeling services
- Customs clearance
- Receipt and storage
- Import management – for SIRO studies only
- Storage of controlled drugs
Why SIRO Clinpharm?
Over the past 10 years, we have worked with several large and small biopharmaceutical companies and have successfully executed close to 300 projects. Our SOPs and work practices which are compliant to ICH-GCP guidelines ensure high quality deliverables with reduced error rates. We have successfully passed several government and sponsor audits which is a testimony to our high standards of quality.
Some of our other services include medical writing which will assist in getting your research published, as well as clinical data management.
For more information email us at bd@siroclinpharm.com or contact us today.
Clinical Operations
Clinical Data Management
Medical Writing
Biostatistics and Statistical Programming
Clinical Trial Supplies
Pharmacovigilance