Services
Comparator Sourcing
- Capability for Global Sourcing of Comparators.
- Supply Chain Management with Cold Chain Maintenance and Quality Checks.
- Sourcing in Compliance to Regulatory requirements and Documentation for Batch Traceability.
- Full Proof Documentation and Regulatory Compliance.
- Sourcing by Maintaining Sponsor and Trial Confidentiality.
Clinical Supplies Manufacturing and Blinding
- Strategic tie up with Globally approved (EU/WHO/USFDA) Manufacturing sites for manufacturing of: i) Investigational Drug Formulations . ii) Placebos for Different Drug Formulations.
- Formulation Blinding by Using Double Blind Technology i) Blinding of Oral Solid Dosage Forms of Marketed Reference Products. ii) Blinding using Over Encapsulation Technology. iii) Formulation Blinding for Double Blind /Double Blind Double Dummy Trials.
- Support for formulation and analytical technology transfer
Clinical Supplies Blinding, Packaging and Labeling
- Blinding
i) Development of Clinical Trial Supply Management Strategy from Study Protocol Stage.
ii) Designing of Blinding Strategy for all Designs of the Study (Open Label, Double Blind, Double Blind Double Dummy,Crossover etc.).
iii) Blinding of Investigational Medicinal Products Provided in Following Primary Packaging:
a) Bottles
b) Blisters
c) Vials
d) Prefilled Syringes (PFS)
e) Ointments, Creams in Tubes
f) Suspensions in Bottles
g) Sachets Containing Granules
h) Inhalers
- Packaging and Labeling:
i) Primary and secondary packaging for all designs of clinical trials (Open Label, Double Blind, Double Blind Double Dummy, Crossover etc.).
ii) Blister packing, bottle packing and pouch filling capabilities.
iii) Codification for Product Traceability .
iv) All types of Clinical Supplies Label generation.
a) Label Text Design, Translation, Country Specific Regulatory Review & Generation of Following types of labels:
– Single Panel and Two Panel Labels.
– Multiple Panel & Booklet Labels.
– Scratch off labels.
b. Generation of Emergency Code Break Envelopes/Unblinding Envelopes.
c. Generation of Randomization Codes and Kit list.
d. Subject Specific Pack Design to Kit Assembly.
e. Clinical Supplies Walleting.
f. Capability to handle Secondary Packing for all dosage forms including temperature sensitive products.
Storage and Distribution
- 6000 sq.ft. Storage and Distribution facility with available space of 600 Pallets
- Storage and Distribution in Compliance to guidelines of GMP, GDP, WHO and country specific regulations
- Storage and distribution of IMPs at 15-25C , 2-8C , -20C & -70 C
- Restricted and controlled access to storage areas
- Online Temperature Monitoring and ample back up support
- Strategic Tie Ups with Global Clinical Supplies Depots for Global Distribution management
- Global logistics supply partners for distribution
- Separate area for Return Management and Destruction
- Just in time Labeling facility for Extension of Expiry/Retest Date or Ancillary Labeling
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IXRT (IVRS/IWRS) Services
- Outsourced activity from Strategic Partners with 21 CFR Part 11 Compliant Systems
- Automated and Customizable supply/re-supply schemes
- Drug Accountability and Reconciliation Tracking
- Seamless Integration with EDC, CTMS, eCOA and more
- 21 CFR Part 11 Compliant, Highly configurable, Scalable and Flexible System
- Covers a whole range of Randomization Methods
- Real time Customized reports and Data exports
- Helpdesk Facilities with 24×7 Support