Comparator Drug

[compartordrug-blog]

Comparator drug sourcing beyond compare

We provide a comprehensive solution for comparator drug sourcing—from strategic supply assessments to procurement, logistics, and documentation. Caligor minimizes the operational, financial, and regulatory risks associated with comparator sourcing, freeing you to focus on the business of product development.

Partnering with Caligor offers you a range of advantages beyond compare.

Quality Assurance

Global Sourcing

Supply Logistics

Customer Commitment

Quality Assurance

200% quality checks, inspecting each product independently by two quality professionals, to identify any product issues, including packaging and labeling integrity, before shipment.

Supplier audits, including on-site visits, to verify that suppliers meet Caligor’s rigorous quality standards.

Temperature control at every step to ensure compliance with cold-chain or ambient temperature requirements.

Detailed documentation, including certificates of analysis and conformance, pedigree, BSE/TSE, and other documentation as required by specific countries.

Qualified Persons (QP) on staff who certify products in accordance with EU directives for pharmaceutical storage and distribution.

Adherence to quality standards, including ISO 9001 accreditation and compliance with GMP/GDP standards.

Robust SOPs to ensure full batch traceability in the event of a product recall.

Our extensive quality processes and vigilance ensure your confidence in the comparator drugs we provide.

Global Sourcing

Need a comparator drug for a clinical trial in Croatia, Russia, or South Korea? Count on Caligor. Our global reach enables us to provide innovative procurement strategies to meet virtually any sourcing requirement, anywhere. Our ever-expanding supplier network extends to dozens of countries in the Americas, Europe, and Asia. Our global approach offers you:

Reliable supply relationships, enabling us to meet your supply needs—including hard-to-get comparators—within your timeframe.

Flexibility—whether you need a sample pack or a large supply with single lot and maximum shelf life.

Manufacturer-direct sourcing, enabling us to minimize supply chain risk and meet special requirements, including coordinating special production runs to meet your timing needs and negotiating continuity of supply with a specific formulation for multi-year trials.

On-site QP audits of our global suppliers to ensure they meet our quality standards for sourcing, storing, and distribution.

In-depth knowledge of local regulatory requirements as well as cultural considerations, allowing us to provide you with appropriate solutions for specific countries.

Caligor’s global network and international approach to comparator sourcing and supply enable us to deliver the optimum solution for your clinical trial—anywhere, anytime.

Supply Logistics

Avoiding costly delays in your clinical trial is paramount. In addition to securing a reliable supply of comparators, we have optimized our logistics processes to expedite delivery while mitigating risk at every step in the supply chain through:

Quality and security monitoring to ensure product integrity and minimize the risk of counterfeits from procurement through delivery to your trial site. We comply strictly with GMP/GDP standards.

Temperature control at every step—throughout our storage and distribution facility as well as during transit—to comply with each product’s cold chain or ambient temperature requirements.

Rapid processing of shipments—within 24 to 72 hours—to maximize shelf life and minimize the risk of costly excess product at the clinical trial site.

Careful auditing of third-party couriers by our in-house QP to ensure compliance with our quality standards, including temperature control, monitoring, and documentation.

Our U.S. and UK logistics teams never forget that every shipment of pharmaceuticals plays an important role in improving the lives of patients.

Customer Commitment

We are there for our customers, around the clock. We focus on building long-term relationships founded upon the success of our customers’ clinical trials.

With operations on both sides of the Atlantic and people around the globe, we work across time zones and cultures to ensure rapid response—whether you have a question that demands our expertise or a special request. We strictly protect customer confidentiality at all times.

[compartordrug-blog]

Comparator Dug By Bilcare

It’s good to see drug developers addressing the issue of comparator drug sourcing and working hard to change the way they manage comparator products in clinical trials. Getting comparator sourcing right is crucial because there is increasing pressure from patients and payers to develop drugs that are substantially better than existing treatments. But managing comparator drugs has grown vastly more complex in today’s environment; where clinical studies are conducted in remote locations and biologics development demands sophisticated cold chain supply capabilities.

One of the most pressing challenges they identified was a lack of fully robust supply chain management practices. After working extensively with clinical teams on comparator drug sourcing for the past several years, I agree. A major reason for this supply chain weakness is that companies are so shocked at the high cost of purchasing comparator that they become overly distracted by this line item rather than looking how they could save money and mitigate risks overall by taking a more strategic approach. We address the importance of thinking strategically and avoiding a procurement-driven mindset in a new e-book on the subject.

When it comes to comparator drug sourcing for clinical trials, there are four essential elements to make the process as painless as possible.

 An unmatched geographic footprint with the capabilities and capacity for central and      local sourcing, regulatory support and transportation management in Asia,Latin America and Eastern Europe, as well as the United States and  European Union;

 An established  sourcing network of trusted industry relationships that enables us to      acquire comparator products directly from innovator companies or from  qualified wholesalers at favorable pricing thereby reducing both the costs and risks of counterfeit drugs;

 The financial  strength necessary to support procurement activities in an efficient way that limits financial risk.

Advanced planning, a thorough analysis of the clinical protocol, strategic thinking and an integrated supply partner. All of these considerations will go a long way toward making comparator trials less costly and frustrating.