Providing Sponsors with the right CTS outsourcing solutions.
CTSS can help you the Sponsor choose the right CTS vendors for your specific study by negotiating the right price and terms for the required product or service whilst meeting your budgetary and timeline constraints without compromising on quality or compliance.
Whether you need to source a comparator, get advice on regulatory issues, audit a site, select the right packaging or IRT vendor or select a reliable logistics partner – CTSS can help you to make the right choices so that your product arrives to the site and the patient on time and in perfect condition.
Here are some of the products and services we can help you find:
API, Drug Substance, Reference or Comparator Drug Product, Lab/Analytical work, CMO services (CMC/formulation development, blinding, packaging, labelling, kitting etc) QP release/regulatory compliance advice, site auditing, IRT/IMS/DSM services for better planning, forecasting, supply and re-supply of kits to sites, temperature controlled S&D including depot selection, finding the right logistics partner and packaging solutions to maintain drug integrity in transit.
Benefit from potentially huge cost savings on comparator drug by identifying the in-country Wholesaler/s or Distributor who can supply when the Innovator remains uncooperative. Understand how to reduce the risk of counterfeit entering the supply chain through advanced due diligence controls of both the drug product, the supplier, the pedigree and the manufacturer. Ensure you get the right compliance documentation required such as COA, BRC, SOA, EUD, ES, BSE/TSE’s & GMPC’s so your comparator isn’t refused an IA from the CA.
CTSS has experience in supporting clients with protocol design issues specific to comparator drug such as drug selection, assessment of ongoing drug availability, centrally sourced drug acceptability by CA’s, drug regulatory status (IMP/NIMP) and study country selection.
Understand the Pros and Cons of working with a multi-national CMO corporation who provide the highly attractive but often expensive “One-stop-shop solution” and excellence across the value chain or several smaller vendors who may have a more innovative approach, faster response times, less bureaucracy and greater flexibility in terms of pricing and terms of trade.
CTSS can help you shortlist vendors and develop, submit and review RFQ’s & RFP’s.
We can assist you in defining, managing and improving these Sponsor-vendor relationships through setting goals, expectations and mile stones, creating a culture of open communication and ideally trust. Gain support in leveraging your larger Suppliers with risk sharing and mitigation initiatives through a partnership approach – if a CAPA won’t cut it if things go pear-shaped and it’s their bottom line at stake, they will be less likely to under-perform in the first instance.
Achieve a greater level of oversight through the development of effective reporting, KPI’s and performance metrics review.
We can develop customised MSA/QTA contracts that define your relationship from a legal perspective and protect you financially whilst ensuring you get the right levels of quality, compliance and service.
Quality and Compliance training is also available through CTSS’s partners who are all licensed, qualified and experienced leading industry experts who can offer the following:
GxP site audits
In depth review of quality systems/manuals/SOP’s.
Provide training and workshops to improve cross-functional understanding of clinical supplies, reduce risk, increase compliance and improve performance, knowledge and efficiency.