Agile, resourceful and personal no matter what. great people, great work, real results

Transcription

1 Agile, resourceful and personal no matter what

2 40+ Years in business 285 Reproductive toxicology studies on site in the last five years World class services with a heart In a fast-moving, ever changing sector, our agility, creativity and unusually personal client relationships make all the difference. We are a long-established, vastly experienced contract research organisation specialising in non-clinical toxicology studies. As an independent, privately held and financially sound company, we are valued for the quality of our work, the skill and resourcefulness of our people and the advanced technologies and methodologies that we continually invest in. And with no parent company to slow us down, we simply get on with what we do best. Working across the drug development, crop protection and chemical safety sectors, our expertise spans the full spectrum of modern research programme needs, including forward-looking areas such as biomarkers. 2 At the heart of all that we do is extraordinary service you could even call it the old-school way. Throughout our 40 years of business, we ve held tight to our personal touch, which means great communication and on every level. Our clients talk to people they know, have direct contact with study directors, get clear and regular feedback and never get lost in a faceless process. Add that to our outstanding capabilities, determination to meet deadlines and flexibility to react quickly as needs change and you have a progressive, go-getting world-class CRO that is always on your side. 3

3 Involved and responsive Our tremendous expertise, long practical experience and ability to meet the highest regulatory standards support research programmes for an increasing range of needs. The scientific and technical quality of our work is internationally recognised, with studies often exceeding regulatory requirements. But what defines us is how we go about it. Open and personal relationships may be an overused phrase but for us it s how we ve always worked with our clients. Mutual trust enables us to plan jointly in a way that makes best sense for your development programmes. Direct contact including between our scientists and yours keeps communication flowing and timely, and our set-up means that we stay flexible and responsive to support any changing needs. We are also sticklers for deadlines, however challenging, and regularly beat agreed timescales. 4 We work fast and efficiently, backed by best-of-breed technology and instrumentation, for which we earmark an unusually high investment budget. We put a lot more into strategy development proposals than most and unusually, we factor in the early stage of a product s development. We suggest best study and route types, and come up with creative ideas for achieving your aims in the most cost-effective and sciencebased way without compromising quality. In a nutshell, we help you optimise your non clinical strategy. Experienced senior scientists are always at the forefront of leadership, planning and management, and stay closely involved from first to last. Our study directors are all highly experienced scientists, and programme and account managers have scientific backgrounds. Our teams work together collaboratively and are often deliberately small to ensure close links to managers. 30+ FIH development programmes Over 30 fully managed FIH development programmes in the past 5 years. Our clients benefit from stronger customer service, greater flexibility and a faster response. In other words, we offer better value for money. 5

4 60+ Our pathology team have over 60 years study experience. 3KEY SECTORS: Knowledgeable support for key sectors The strength of our expertise provides invaluable support to companies across the drug development, crop protection and chemical safety sectors. Our highly qualified study directors have considerable experience, including at other toxicology research centres, with most holding advanced toxicology qualifications. Uniquely to our company, those working in reproductive, general and juvenile toxicity are cross-trained across these disciplines, providing valuable continuity for linked programmes. Our pathology team have over 60 years study experience and are all either fellows or associate members of the Royal College of Pathologists. Our programme and account managers are also scientists, ensuring knowledgeable coordination and communication across all aspects of every programme. DRUG DEVELOPMENT: CROP PROTECTION: CHEMICAL SAFETY: Our services span part or all of regional and global drug development programmes and offer extraordinary value for money, flexibility and speed of response. We can take care of an entire project from pre clinical stages to regulatory submission and marketing approval work up to or solely at a specific phase, or look after a defined development component. Using both rodents and non-rodents, including dogs and mini-pigs, we work across a comprehensive range of therapeutic areas and on a variety of drug types, including small molecules and biologicals. Our clients particularly appreciate the way we turn data into decisions and help define the best route to take, as well as our prompt and timely delivery of high quality reports for each study within a development programme. We offer a wide range of high quality, development services for crop protection for agrochemical companies around the world, and help develop effective new agrochemicals that make a real difference to people s lives. With strong science and technical knowhow and performance to their name, our scientists have been helping our clients meet the regulatory requirements for 40 years. The experience that our scientists and programme managers bring to projects means that we understand the science and the regulations, enabling us to deliver the right studies at the right time. Drawing on their expertise, they provide valuable advice every step of the way, including proposing cost-effective ways to bring your product to market quickly. Our thorough knowledge of all regulations, including REACH, ensures the very best resource for your studies and a robust partner to support your global regulatory submissions. With over 40 years experience under their belt and strong scientific and technical capabilities, our scientists work closely with you, making sure that the study you require is scientifically sound, regulatory compliant and delivered on time. The highest levels of quality and service come as standard, with a broad range of practical support, consultancy and problemsolving keeping projects running super smoothly whether a single study or a package of work. 6 7

5 One of the few CROs offering juvenile toxicology studies in mini-pigs Forward-focused expertise Meeting the study needs of evolving research and new areas of focus is integral to our pivotal role as a forward-looking CRO. Our services include: 8 General toxicology including mini-pig Reproductive toxicology Juvenile toxicity including mini-pig Standalone PK studies Genetic toxicology Biomarkers Analytical chemistry for formulation analysis Bioanalysis Pharmacokinetics and toxicokinetic reporting Clinical pathology Pathology Histotechnology Contract histology and pathology Bioanalysis Foetal pathology includes advanced Programme management liquid chromatography and Sciex tandem mass spectrometry instrumentation and software Along with a full spectrum of high quality services to meet modern needs, we offer considerable in-house biomarkers expertise. Headed by a senior biomarkers scientist with extensive pharmaceutical industry experience, we provide a de-risking strategic service designed in conjunction with our clients. Our support includes specialist advice to help you identify suitable biomarkers or panels of biomarkers, and developing and validating the methodology for analysis. We are a leading juvenile toxicology specialist and one of the few CROs offering studies in the mini-pig as a favourable alternative to other non-rodent species. We have an extensive collection of comparative pathology data in juvenile rats and mini-pigs at a range of ages, including scanned digital images for training and reference use, and have undertaken research projects to develop microsampling techniques to reduce animal use in juvenile rat studies. As a world leader in reproduction toxicology, the volume of studies that we run relative to our size is unique amongst CROs, with our widely recognised expertise encompassing the full range of regulatory and investigative reproduction studies. Our dedicated foetal pathology support team is experienced in all aspects of foetal evaluation for rats, rabbits, mice and minipigs, including single and double skeletal staining techniques, and is backed by automated collection of developmental and behavioural data. Specialist formulation analysis is carried out in a superbly equipped laboratory, which includes state-of-the-art HPLC and UPLC instrumentation, and is routinely conducted to support toxicology and genetic toxicology studies. Our extensive analytical experience spans solutions and suspensions in a wide range of matrices as well as dietary admixes. Our expert bioanalysis and toxicokinetic reporting capabilities extend across a variety of matrices and are led by a bioanalyst with over 20 years experience and full pharmaceutical industry training. 9

6 A breath of fresh air The thought and care that goes into every piece of work that we undertake is reflected in the location of the Sequani campus. Situated on the edge of the historic rural market town of Ledbury in Herefordshire, our setting means a lot to our staff and our clients. Surrounded by glorious countryside but within quick reach of the town s full amenities, our environment is the perfect inspiration for calm, focused work by people who thoroughly enjoy being far from the madding crowd. With none of the stresses of wall-to-wall traffic, we are just three hours by direct train from London and across the road from the station, which makes visiting us here an absolute pleasure. 10 A magnet for talent. Our campus is a magnet for the very best people in the industry, including eminent scientists. We look after our people exceptionally well, giving them every opportunity to develop their careers, undertake continuing professional development training and expand their horizons by working in different departments. As with our client relationships, we all work in a close-knit and friendly way, with senior staff very approachable and managers doors always open. Consequently, most people have been with us for many years and we have a very low staff turnover. We make sure our technical expertise extends throughout each study team The Sequani campus is home to around 200 hard-working, determined people. Most of them have been with us for many years. We invest in our talented staff through a comprehensive CPD programme, and sponsor further qualifications, such as IAT qualifications and Masters degrees. 11

7 trust Everyone will tell you they try to build trust with their clients, but at Sequani we really feel we re getting it right. It s what drives everything we do. Sequani Limited Bromyard Road, Ledbury, HR8 1LH United Kingdom phone: +44 (0) business.development@sequani.com website: