Lekoko PMC is a specialized Clinical Trial Material storage and distribution facility. Strict adherence to GDP, Quality Assurance Systems and GCP ensures optimum storage conditions for Pharmaceutical product. The facility is run by a Pharmacist and all personnel are medical professionals trained in Standard Operating Procedures. Individual treatment and attention to detail is a key factor in our service delivery.
We currently receive and distribute Clinical Trial Material for clients such as Sanofi Aventis, OnQ, Novartis, Triclinium and a number of others. We can accommodate unique specifications for different clients and will meet individual needs in line with the nature of Clinical Research work.
Services Available and Costing
- Receipt, and assistance with importation and administration of incoming Clinical Trial Material
- Safe and Secure Storage of all product
- Distribution of Investigational Products to investigator sites, within given time frames according to sponsors/ CRO requirements
- Sourcing and provision of adjunct meds
- Sourcing and supply of site requirements
- Receipt and handling of returns
- Cold Chain storage and temperature controlled distribution (various temperature ranges including 15-25 °C controlled), with data logging
- Provision of legally compliant, effective storage and handling facility for Investigational Products on behalf of Sponsor/ Manufacturer/ CRO
- Internet facility for order/ e-mail or fax
- Internet based tracking for shipments
- Reports available in agreed format
- Storage of Archived Data
- Training on IP handling
Costs are calculated on an Activity based costing basis tailored to client requirements. Thus ensuring no wastage as costs are based on actual work done and not percentages i.e. Larger volume more economical costs.
Quality Assurance, GDP and GCP
A Quality Assurance Programme with strict Quality Control is applied incorporating Standard Operating Procedures (SOPs), QA Auditing and inclusion of specific GCP guidelines. A qualified, registered Pharmacist is in attendance at all times. All personnel are qualified and trained while also having confidentiality undertakings.
SOPs applied ensure safe receipt, handling and storage, processing of orders, distribution to investigator sites and returns. Complete records are maintained for receipt, shipment, return and destruction of investigational products. Product batch tracking enables easy application of recall, if necessary. Stability of product is retained through temperature and humidity control.
Systems are validated.
Secure Facility - access controlled and alarmed, linked to a 24 hour control room with armed response.
Smoke and Fire detection systems are in place.
Full generator (electrical power) backup automatically controlled and monitored.
Environmental control – Temperature Controlled Warehouse, thermostatically monitored with full power Generator back-up.