IDIS CLINICAL TRIAL PROCUREMENT STRATEGIES. A trusted source for all of your global comparator needs

Transcription

1 IDIS CLINICAL TRIAL PROCUREMENT STRATEGIES A trusted source for all of your global comparator needs

2 WHAT YOU NEED, WHEN YOU NEED IT We typically source over 90% of comparators directly from the manufacturers themselves, many of whom we have worked with for nearly 30 years. Often, comparator procurement is approached reactively and transactionally. However, as clinical development becomes more complex and costly, the risks associated with this approach can increase substantially. There is a better and more secure way to access and manage comparator drugs procurement by working in a strategic partnership with Idis. We can add value and expertise to your clinical development programmes by developing reliable, cost-effective comparator solutions giving you choice and peace of mind. With our unrivalled ability to work with manufacturers to gain access to comparator drugs and our dedicated team of experienced specialists, we re well positioned to be an integral part of your comparator plan. IDIS OFFERS YOU A RELIABLE STRATEGIC ALTERNATIVE TO RISKY TRANSACTIONAL WHOLESALING.

3 Wholesalers might help you source comparators, but can they mitigate risk like we can? Working directly and confidentially with manufacturers, Idis: Provides advice and project management leadership to our partners, enabling innovative strategies Develops tailored solutions for challenging projects, mitigating associated risks along the way Identifies reliable comparator product options with global supply chain integrity Promises to reduce delays and significantly lower your total comparator acquisition costs

4 MITIGATING THE RISKS ASSOCIATED WITH COMPARATOR PROCUREMENT If you have concerns about potential risks in sourcing comparators for your trials why not consult with Idis today to mitigate those risks? Idis in-depth knowledge of country-level regulations ensures compliance, supporting the success of your clinical trials programmes Idis has the ability to locate reliable and secure access to comparators, keeping your clinical development timeline on schedule We remove the risk of counterfeit medicine entering your comparator supply chain, protecting the safety of patients Idis works as a true partner providing market intelligence that informs a clear strategy for secure access to comparators and documentation at the lowest cost You can rely on Idis to deliver on our promised lead times, so you can plan your timelines accurately Robust storage and distribution with swift resolution of temperature excursions where needed, means that Idis helps to avoid wasting expensive material and stay within budget DID YOU KNOW THAT OUR RELATIONSHIPS WITH PHARMACEUTICAL AND BIOTECH COMPANIES SPAN 30 YEARS? IDIS HAS BEEN A TRUSTED PARTNER TO THESE ORGANISATIONS THROUGHOUT, PROVIDING REGULATED ACCESS TO THEIR LIFE-SAVING MEDICINES FOR PATIENTS AROUND THE WORLD. IN A TYPICAL YEAR, IDIS PROVIDES ACCESS TO OVER 100,000 PATIENTS ACROSS 130 DIFFERENT COUNTRIES AND WE SPEAK OVER 22 LANGUAGES IN ORDER TO FACILITATE THIS.

5 Strategic comparator solutions The earlier you consult with Idis the better. We ll protect you from the potential risks you face when sourcing comparators by helping you to select the right comparator management option to meet your clinical development programmes. We ll find the most robust source of material and negotiate the best pricing in each case so that you have peace of mind that your trials will not be derailed by a lack of quality comparator product or the documentation to support it. Regulatory experience Our consultants are in regular communication with key regulatory authorities to guarantee global regulatory compliance. We also have mature relationships with manufacturers with whom we work closely as a trusted conduit for their medicines. Operational confidence We can enter into long-term agreements with manufacturers, guaranteeing genuine products instead of parallel imports or counterfeits and we provide full batch traceability. Commercial benefits We ensure cost-effective strategies by collaborating directly with manufacturers to schedule production runs to meet your comparator needs and timing. So we ensure a long-term supply, while maintaining flexibility and commitment to production timelines. By proactively planning for demand and ensuring strategies to reduce wastage we provide significant, sustainable savings. How much could we save you? Consult with Idis today.

6 A REAL-LIFE EXAMPLE OF OUR STRATEGIC COMPARATOR SOURCING CAPABILITIES Situation A large global pharmaceutical company was conducting a global Phase 3 open label extension study for their promising new treatment option for patients with a specific form of cancer. They needed to source over 1,000 packs of a comparator product for each of four global regions using a staggered approach to minimize overage. Objectives Secure robust supply for the entire duration of the study, all regions (EU, ASIAPAC, LATAM and USA) Proactively identify new opportunities for strategic cost savings THE IDIS GLOBAL SINGLE SOURCE APPROACH SAVED OUR PHARMACEUTICAL COMPANY PARTNER MORE THAN $5 MILLION COMPARED TO THEIR BUDGET FOR THE SAME VOLUME OF PRODUCT.

7 Solution Idis secured a signed equivalency statement, thus allowing a global single source of the comparator We established a supply agreement directly with the manufacturer for the duration of the trial, mitigating supply risk Centralized control over product purchase was implemented in order to ensure global product consistency and compliance for the study Results The total comparator requirement for 13 countries was procured, stored and supplied by Idis in line with patient recruitment and was staggered across a 5-year span to minimize overage The Idis Global Single Source approach saved our Pharmaceutical company partner more than $5 million compared to their budget for the same volume of product We held the comparator product in Idis state-of-the-art warehouse facility, shipping directly to country sites when needed. This approach reduced overage and introduced significant operational efficiencies

8 IDIS CLINICAL TRIAL PROCUREMENT STRATEGIES Specialists in identifying the best, risk-mitigated comparator strategy for each trial and providing partners with the lowest total acquisition cost for the product Unrivalled ability to work directly with manufacturers to source material Guaranteed regulatory compliance and secure product documentation Guaranteed genuine products and full batch traceability Guaranteed long-term, flexible comparator supply Proactive planning for significant, sustainable savings Weybridge UK Copyright Idis 2015 Talk to your Idis expert in Idis Clinical Trial Procurement Strategies Mark Ware, Head of Clinical Trial Procurement T +44(0) M +44(0) Idis House Churchfield Road Weybridge KT13 8DB United Kingdom mware@idispharma.com Or visit