Clinical Trial Supplies. Establishing Firm Grounds for your Trials

Transcription

1 Clinical Trial Supplies Establishing Firm Grounds for your Trials

2 Clinical Trial Logistics & Supplies The success of a clinical trial largely depends on its conduct, data management, statistical analysis and managing regulatory submissions. Apart from these core activities, a vital part of any clinical trial is the logistical support which ensures that the patient receives the correct investigational product. For the trial to have its desired effects, it is essential that the IP reaches the trial sites in time and with no compromise in its quality. With increasing R&D pressures, companies are looking for cost effective, impeccable supply chain management services, which best suit their trial needs.

3 SIRO Clinpharm Clinical Logistics & Supplies Services We are one of the few clinical research organizations in the Indian sub-continent to offer clinical trial supplies (CTS) management services. Our facility, fully equipped to deliver best-in-class clinical logistics solutions, is located in Mumbai and is well connected to all parts of the country. We offer end-to-end supply solutions, from the import of investigational product to distributing and retrieving the same from investigational sites, and nally destroying it under appropriate conditions. Keeping in mind today's stringent regulatory needs, we have put in place comprehensive standard operating procedures (SOP) 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 and humidity monitoring and adequate power back-up ensure that the temperature is always maintained within limits. We understand and maintain con dentiality for all our clients products. Storage Management Strategy & Planning Project Management Import Support Facility Return & Destruc on Labeling Support 3 Site Supplies Cer fica on

4 Strategic Planning Planning is key, when the quality and integrity of the IP is in question. Unpredictable delays, regulatory hassles, could lead to crippling effects on the clinical trial schedules. The clinical logistics team along with the clinical development team strategically designs logistical solutions that are customised and aligned to the client's trial plans. SIRO Clinpharm clinical logistics team proactively coordinates with the sponsor, quality control teams, logistics team and third parties that may be involved. IP Management As one of the leading CROs in India, we have a very good understanding of the clinical development process and the logistical requirements. With more than 150 projects undertaken for multinational clients, through this facility and with the help of experienced personnel, we have been catering to global biopharmaceutical companies by supporting their complex and high value requirements of IP handling and allied products.

5 SIRO Clinpharm Clinical Logistics team is adept at deciphering information from various types of randomization systems (E.g. IVRS) keeping a check on the distribution channels monitoring the entire supply chain with strict inventory management mechanism ensuring that each patient gets the correct IP For your investigational product we have the capabilities to manage regulatory approvals for import of trial supplies & release of shipment at ports/ customs clearance. Other services include shipment to investigator sites and retrieval. Storage Management SIRO Clinpharm's storage and warehousing solutions will facilitate ease of shipment management, better control over the logistical activities and help in optimizing costs by reducing overheads and therefore help in optimizing your logistical activities. Storage and warehousing Inventory control and management Storage of non-drug clinical trial materials rd Coordination with 3 party vendors Planning & monitoring supply schedules 5

6 Clinical Trial Storage Facility SIRO Clinpharm has a state-of-art, GMP compliant, clinical supplies storage facility. It is strategically located in the heart of the country, making all corners easily accessible by all means, air, water or land. The facility is continuously checked for quality controls by a dedicated quality assurance team. It has been audited by various multinational companies and inspected by the local FDA.

7 Location Located in Mumbai, we have easy access to the Mumbai airport for imported shipments. We have experience in successfully handling shipments through imports, managing their stringent storage requirements and control the distribution to various sites all across India through our rigorous quality assurance process. Facility The SIRO Clinical Trial Supplies Facility has seen many large to medium pharmaceutical companies successfully manage their investigational products through our services. The facility has 3 types of compartmentalized storage: Ambient : 15 to 25 degree C Cold: 2 to 8 degree C Frozen: -20 to -80 degree C It is equipped with advanced storage technology for all temperatures, with temperature monitors located all across the facility and security systems that ensure the safety of your products. 7

8 Returns and Destruction As the demand for clinical trial supplies vary and uctuate despite rigorous planning, it leads to return of the products from sites and unused / expired warehouse stock which need to be managed effectively by the logistics company. To complete the process of clinical trial, the company must log and account for all supplies. Apart from accounting, the company needs to follow the returns and destruction regulations, which sometimes are different for speci c countries. It is essential to know that the logistics company has a good understanding and a working knowledge of the local regulations. SIRO Clinical Trial Logistics & Supplies team is experienced in managing returns and destructions of clinical trial supplies. SIRO has all the required approvals from the regulatory body for storage, transportation and disposal of hazardous waste. We have teams dedicated for accepting shipments, documentation of stock, maintaining stock records, temperature records, and quality assurance.

9 Quality Assurance Assuring Quality and Compliance With the amount of dollar spending in clinical research, you need to be assured that the supplies for your clinical trial are checked and veri ed at every stage of the logistics process, that they adhere to the stringent guidelines of each geography, and that the process is controlled with oversight from experienced professionals. Taking a step towards ensuring the success of your clinical trial, our logistics team, with its ability to deliver expertise, follows strong internal controls such as robust SOPs with demonstrated effectiveness in all geographies within India.. High quality of deliverables is maintained by quality control personnel who are speci cally trained for clinical trial logistics. SIRO Clinpharm also provides an additional layer of quality assurance for 100% SOP compliance. QC Review Table One of the bene ts of partnering with SIRO's Clinical Trial Logistics team is the experienced team which has worked on eld for more than 15 years. 9

10 Highlights QUALITY ASSURANCE Comprehensive SOPs and work practice documents which are compliant with GCP, GMP, GDP and GSP requirements Successfully cleared 6 local regulatory inspections with no major ndings Continuous monitoring: temperature & humidity are monitored 24x7 through sensors Periodic internal audits FACILITY & LOGISTICS SERVICES Separate quarantine area in each temperature zone Separate room for storage of non- drug clinical trial supplies Domestic distribution of nontemperature and temperature sensitive products Source appropriate packaging solutions and temperature monitors Round the clock power back-up and cooling units to maintain temperature conditions QA Review Table SECURITY 4 levels of security Centralized alarm control Fire alarm systems and re extinguishers PROJECT MANAGEMENT Effective vendor management Shipments sent within one working day after receipt of order Robust issue escalation process Effective project management: risk assessment and mitigation plans

11 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. If you would like to visit our facility, feel free to get in touch with our executives at bd@siroclinpharm.com and we would be happy to help or you can read more about our services at 11

12 Asia SIRO Clinpharm Pvt. Ltd. DIL Premises, Second Floor, Swami Vivekanand Road, Near Tatwagyan Vidyapeeth, Ghodbunder Road, Thane (W) , India. Tel : Fax : Europe SIRO Clinpharm Greece SA 25, Vrana Street, N. Psychiko, Athens, Greece. Tel : Fax : North America SIRO Clinpharm USA LLC. 850 Bear Tavern Road, Suite 302 Ewing, NJ 08628, USA. Tel: Fax: For further information contact us at bd@siroclinpharm.com