Early Phase Excellence Our Specialist Services at a glance Richmond’s long established partnership with a world-class Scientific Advisory Board provides medically driven outcome based solutions and puts us at the forefront of the industry globally About us As a research organisation run by safely. The new site, formally known healthcare professionals, Richmond as Guy’s Drug Research Unit, adds a Pharmacology makes a meaningful world-renowned university and large contribution towards bringing new acute teaching hospital trust to our medicines to market. We interact with portfolio, in addition to St. George’s healthy research volunteers, patients, where we have been based since our clinical and academic specialists in foundation in 2001. Richmond’s long their respective fields, to ensure our established partnership with a world- research meets the highest regulatory, class Scientific Advisory Board provides scientific, quality and ethical standards. medically driven outcome based We are personable, flexible, adaptive solutions and puts us at the forefront to change to meet clients’ expectations of the industry globally. and transparent in the process. Our accreditation by the Medicines The new clinical facilities by the and Healthcare Products campus of Guy’s Hospital and Kings Regulatory Agency provides College London offers state-of- assurance that you will be working the-art premises ideally positioned with a credible organisation that to provide the infrastructure and conforms to only the highest of expertise to conduct complex studies clinical and regulatory standards. Richmond Pharmacology - 15 years of outstanding achievement

For 15 years, Richmond Pharmacology What makes us special has delivered clinical excellence from design to delivery of early phase clinical We are well established in a competitive trials, going from strength to strength in market place and are a recognised a fiercely competitive market place. Our stakeholder on a national, European new research facility is the fourth clinical and global level, helping drive the Full service offering: research unit we will have designed and sector forward. We are • Clinical pharmacology operated and its blueprint is the result of intellectually engaged, adding value by consulting 15 years expertise in running early phase working with our clients to achieve the best clinical research. It combines the long- possible outcomes for them. We are small • Medical writing enough to care and to be personable, yet standing tradition of the site with our • Regulatory applications working practices to match the needs and large enough to perform well in the largest expectations of innovative sponsors. of studies. • CRF design • Clinical conduct We have experience that is held by our long We are highly specialised in Adaptive Phase serving management team and are reputed I, QT studies, Japanese and Patient studies. • In-house volunteer catering for our customer focus, flexible approach Richmond’s volunteer database is the • Drug Free Plasma and strong project management. We have single largest of its type worldwide with • Pharmacy conducted over 300 Early Phase Studies. We over 225,000 registered volunteers actively have developed an efficient approach that seeking to take part in a clinical trial. The • Laboratory allows us to combine different designs into intelligence we gather enables us to make • ECG core laboratory one , leading to objectively faster firm commitments and to adhere to agreed • Data management development times from First in Human to timelines. We are attentive and thorough Proof of Concept studies. Our integrated in our attitude. We deliver a professional platform is designed to streamline every and courteous service establishing long- aspect of Early Phase trials with quality, term working relationships with our clients. integrity and accuracy. TQT and iQT

Richmond Pharmacology develops optimal and cost-effective strategies for TQT waivers

Thorough and intensive QTc Studies Richmond Pharmacology has a globally, All QTc studies are performed well recognised expertise in providing consultancy and expert reports on cardiac in collaboration with world safety, the clinical conduct of intensive ECG studies, core laboratory services Unmatched expertise renowned opinion leaders such as adjudication and the cardiology Our core ECG laboratory provides in cardiological analysis over-reading of automated interval a centralised system for all our studies. measurements. We have expertise in It has the longstanding commercial, statistical analysis concentration-effect clinical and academic reputation of modelling (CEM), reporting and publishing. excellence of St George’s University We have a 10 year track record in in London, a world class provider in conducting QTc studies. We can conduct cardiology. High-precision ECG acquisition ICH E14 TQT studies or use CEM during in our tried and tested clinic allows Japanese bridging and/or early SAD and meaningful ECG analysis with a smaller MAD studies eliminating the requirement sample size, making us the ideal choice for a dedicated TQT study. for the integration of cardiac safety in Richmond Pharmacology FIH and MAD studies. Richmond Pharmacology provides their study data is well respected by clients with FDA compliant state of the art Richmond Pharmacology’s clinical facilities analysis methods, and provides the option and the on-site core lab are a permanent regulators such as FDA, EMA to include a non-pharmacological method set-up offering an unmatched focused of proving assay sensitivity. Richmond’s work environment with no additional costs, and PMDA unique and innovative approach means thereby delivering value for money to that we conduct our studies and prove pharmaceutical Sponsors. We are a leading assay sensitivity as a standard feature. publisher in this area and have publicly This has provided quality data in many accessible credentials. We are proud of non-TQT studies eliminating the need our integrity, our professional growth and for a dedicated TQT study. experience in this field. From First-Time-in-Human Combined to Proof of Concept Richmond Pharmacology actively works to maximise return on our Sponsors’ trials, Adaptive Early having routinely developed and conducted adaptive protocols to support rational “no-go” or “where to go next” decisions. The benefits of using adaptive design can Phase Trials be best exploited in combined “umbrella” protocols, whereby an entire early phase programme from First-Time-in-Human (FTIH) to Proof of Concept (POC) can be performed within one trial protocol in One single centre approach a single centre. Value can be added by integrating ethnic comparison elements for faster development and further drug development can be to POC-flexible protocols, de-risked by integrating intensive cardiac assessments and other biomarkers into simple trial logistics, a combined protocol. enhanced data quality Systematic and logical protocols Our transparent and systematic 3-step Rapid approval approach ensures that all potential adaptive features, their boundaries and Richmond’s established adaptive Phase I programmes from FIH study control mechanisms are considered protocol format enables us to run and fully described to allow continuous entire Phase I programmes, including to POC are performed and learning from data that is being gathered. first evaluation of efficacy in groups Such a strategy allows us to adapt and of patients as part of one protocol completed in 4-9 months modify the trial design without and following a single regulatory undermining the validity and integrity and ethical approval. We have an of the trial. excellent track record for starting studies on time and effectively Competent and Fast Decisions managing ethics and regulatory submissions, with processes that are We have a highly specialised medical team tailored to ensure a minimum of who, in collaboration with our dedicated queries and rejection letters. Richmond Pharmacology has a in-house data management team and proven track record of MHRA multidisciplinary partners, maintain close Whilst progressing through the various communication with our Sponsors for parts of a combined trial, there is and Ethics approval within 4 competent and fast decision making. no need to share interim data with Our goal is to constantly review emerging the competent authority or ethics weeks of submission and quality controlled data to modify the committee, unless there is intention study within the pre-approved limits and to go beyond pre-defined and boundaries to meet the study objectives approved adaptive boundaries. and guarantee a rapid trial progression while focussing on participants’ safety. Japanese studies Richmond Pharmacology’s recruitment database is the largest in Europe containing a panel of over 7,000 1st generation Japanese volunteers

Bridge the gap in your Japanese clinical team next clinical study Richmond’s experienced in-house Japanese team, accounting for 20% of our workforce, By gathering Japanese data sets from includes a Japanese GMC registered doctor, Richmond has successfully Phase I, potential ethnic variations can nurses, study managers and recruitment be detected early on adding value to staff who are involved in all aspects of your completed more than subsequent global development programs. study. The large contingent of Japanese staff Richmond Pharmacology has the experience 60 studies with Japanese facilitates good communication, accurate and expertise to empower bridging reporting of adverse events and helps our strategies. Through our track record of volunteers since 2002 volunteers feel comfortable and looked after accepted submissions we have built up a by a team that understand their concerns strong relationship of trust with Japan’s and needs. Pharmaceuticals and Medical Devices Agency (PMDA) and have an in-depth understanding of the specifics needed to submit a complete clinical data package. Richmond contributes to Japanese annual scientific Experts in Japanese recruitment meetings and has a good The Japanese marketing and recruitment process is managed and conducted in-house. This gives us clear oversight and control over the marketing and recruitment campaigns track record of publications for studies we run with Japanese volunteers. The targeted community outreach campaigns in peer-reviewed journals are driven through our longstanding and well-known brand trials4japanese, generating 60- 120 new Japanese registrations each month, thereby aiding our on-time recruitment record. Our dedicated in-house Japanese recruitment department provides all Japanese volunteers with a personal experience that results in over 40% returning to take part in further trials. Participant Recruitment

Richmond has a database of more than 225,000 healthy and patient volunteers Largest in the UK Richmond Pharmacology is renowned for our recruitment capabilities. Richmond’s database grows We maintain the largest early phase participant database in the UK with at an average rate of 1,000- over 225,000 registered and pre-qualified volunteers willing to participate in clinical 2,000 registrants per month trials. We have pioneered the use of marketing and recruitment methods, our systems and long standing expertise. This allows us to adapt our recruitment efforts to efficiently screen in excess of 25 - The average number of 500 volunteers in a month to place up to 150 healthy volunteers and patients Tried and tested calls received per hour from into the trials ongoing at Richmond. Our dedicated in-house recruitment volunteers looking for teams and personal touch ensure that Up for the challenge volunteers are engaged from the first clinical trials to take part in contact to the last appointment. Our extensive metrics and feasibility assessments offer Sponsors invaluable Our strategic and efficient insight into study acceptability and management, complemented with the suitability of the target population. This ability to modify standard strategies ensures accurate predictions of recruitment due to the unique demands of 31.8% (males) and 28.4% time and attrition rates which benefits the individual trials, allows us to: overall timeline planning for the trials we • Gather homogeneous data with run. As a result, we are able to determine (females) is the average statistical significance in reduced the recruitment effort and identify any sample size conversion rate of subjects from potential challenges the study may present at an early stage development, • Limit participant exposure to what screening to dosed into trials thereby allowing time to address these is essential challenges in a manner that will facilitate run at Richmond since 2001 • Maintain a high (99%) completion study conduct without compromising the rate for volunteers included in trials scientific quality. we run Patient >80,000 patients across studies numerous therapeutic indications registered to our database and looking to take part in a clinical trial

71 subjects with Relapsing Remitting Multiple Sclerosis included in a trial within Complex population Reduced variability 5 months of initiating panels made easy A single-centre approach in preference to recruitment We are specialists in recruiting challenging a multicentre one for the conduct of early- patient panels, bringing these patients phase patient studies presents numerous to our unit from all over the UK. We benefits: have extensive experience of recruiting • Your trials are conducted in a single >99% of subjects included a multitude of complex volunteer panels centre dedicated to clinical research including but not limited to patients with resulting in high quality homogeneous in trials since 2012 have gone diabetic neuropathy, multiple sclerosis, data acquisition. schizophrenia and amyloidosis. One of our on to complete the trial proudest recruitment achievements is the • This has the potential for requiring recruitment of genetically defined rare fewer patients to demonstrate statistical they started patients for a global Phase 3 study. significance producing valuable data at Richmond Pharmacology was the first centre an early stage of development. worldwide to dose a patient and the largest • Our specialised and experienced team recruiting centre for this pivotal study. work for you to recruit patients in a cost and time efficient manner. 47 days - the longest in house High standard of care stay by patients involved in Richmond Pharmacology facilities are adaptable to accommodate the requirements clinical trials with Richmond of different patient populations and study procedures. Richmond’s clinical wards can accommodate patients for studies requiring long-term in-house stays; creating a safe and research-focused environment, whilst at the same time being a welcoming environment for healthy volunteers and patients. Full Service Clinical Trial Management

Richmond Pharmacology believe that effective project management is the key to meeting study timelines. Our team of highly experienced experts meet, plan and document every step of your study providing the following services:

Medical Writing Regulatory Applications Richmond Pharmacology’s Medical Writing Richmond Pharmacology undertake Department has considerable experience all regulatory matters on behalf of our in producing Clinical Study Protocols and clients, depending on their requirements. Pharmacy Study Reports according to ICH guidelines. In combination with our medical writers, Each protocol is developed in collaboration our experienced project management team Our clinical trials pharmacy has been • IMP return, destruction and/or retention with the Sponsor in order to fulfil Sponsor will compile all necessary documentation, designed, commissioned and is operated as required on study completion requirements and objectives. All protocols including writing the information for in compliance with the MHRA best practice • Sourcing of comparators and NIMPs are written by Richmond Pharmacology’s volunteers, informed consent form and and GMP guidelines. for clinical trials medical writing team, with input from completing the on-line IRAS application It is staffed by pharmacists and technicians • Sourcing, preparation and supply Richmond Pharmacology’s medical team form. Richmond Pharmacology can obtain with extensive experience of IMP of controlled drugs including the Medical Director. The Clinical necessary documentation and specialist preparation for clinical trials and supervised Study Report is the final deliverable and opinions for ethics submissions in order We have the ability to store IMPs in by two licensed GMP Qualified Persons the one document for which the study will to obtain approvals in a timely manner. a wide range of conditions to meet (QPs). be remembered. Our experienced Medical We work closely with many ethics Sponsors product requirements. Writing Department works alongside the committees, local and nationwide, and As standard we offer to our clients the Ambient and storage temperatures are clinical, data management and statistical will select an ethics committee based on following pharmacy services: continuously monitored by a sophisticated analysis team throughout the study to study needs. Our Principal Investigators • IMP manufacture/ assembly of solid, temperature control system, which is ensure accurate representation of data and will attend the ethics committee meeting semi-solid and liquid dosage forms alarmed as a safeguard against any results of the clinical study. to participate in discussions facilitating excursions. The temperature data is • Batch QP Certifications a smooth approval process. We also exported, signed off electronically and organise and oversee the CTA application • Expert advice and input into IMPD made available to our Sponsors at regular to the MHRA if required. We have development intervals of their choosing. submitted numerous CTAs to the MHRA • Preparation of study specific Pharmacy Richmond Pharmacology Pharmacy on behalf of our Sponsors, often gaining Manuals Accreditations: approval after the first review of the study • IMP label design - MHRA submission • Licensed by the MHRA for IMP documentation. ready manufacture - MIA(IMP) Licence 21878 • Importation of IMPs from non-EEA • Licensed by the Home Office to possess countries and issuing QP Declaration of and supply Controlled Drugs Importation • Registered with the General • IMP dispensing, accountability and Pharmaceutical Council of Great Britain reconciliation Data management Richmond Pharmacology offers a high systems. Our service is comprehensive, Featured quality data management service which is spanning from CRF design, database flexible, efficient and tailor-made to our build, data entry, query management, clients’ needs. medical coding, database lock, through to Publications export of final datasets. We are capable The Data Management department boasts of delivering clinical trial data in various a vastly proficient and integrated team formats including CDISC compliant datasets Thorough QT & iQT Adaptive Phase I of data managers, programmers and or another format of our client’s choice. statisticians with many years of experience Thorough QT study of the effect of Three steps to writing adaptive study in the clinical research sector. They work Data is analysed by Richmond’s expert intravenous amisulpride on QTc interval in protocols in the early phase clinical to the highest standards that guarantee statisticians who are involved in all key Caucasian and Japanese healthy subjects. development of new medicines. Lorch delivery of accurate data on time and aspects of a project from protocol and CRF Taubel et al. Br J Clin Pharmacol. 2016 doi: et al. BMC Medical Research Methodology within budget. design to statistical reporting. They have 10.1111/bcp.13128 2014, 14:84 academic backgrounds with vast industry Our ‘Under One Roof’ approach ensures Comparison of digital 12-lead ECG and The practical application of Adaptive experience in all phases of clinical trials that the data management works closely, digital 12-lead Holter ECG recordings study design in Early Phase Clinical Trials. across numerous therapeutic areas. in a co-ordinated manner with the clinic. in healthy male subjects: Results from a Lorch et al. Eur J Clin Pharmacol 2012; This reduces query management effort, Richmond’s Data Management recognises randomized, double-blinded, placebo- 68(5): 543 -551 guaranteeing the fastest time to database the diversity of our clients’ preferred controlled clinical trial. Wang et al. Annals lock by eliminating inefficiencies often methods of collecting, analysing and of Noninvasive Electrocardiology 2016; Japanese Studies encountered when these two reporting clinical data. By listening and 00(0):1-7. Pharmacokinetics and Pharmacodynamics services are provided separately understanding these preferences we are Single Doses up to 800 mg of E-52862 of Lomitapide in Japanese Subjects. by different companies. able to adapt our standard processes to Do Not Prolong the QTc Interval Taubel et al. J Atheroscler Thromb. 2016; meet the needs of our clients. No matter - A Retrospective Validation by We offer paper-based and electronic data 23(5):606-20. how big or small they are, we provide a management services using our Oracle Pharmacokinetic-Pharmacodynamic bespoke and, more importantly, superior Pharmacokinetics, Safety and Cognitive Clinical® platform and a number of EDC Modelling of Electrocardiography Data service time after time. Utilising the Effects of a Meal on QTc to Function Profile of Rupatadine 10, 20 Demonstrate ECG Assay Sensitivity. Taubel and 40 mg in Healthy Japanese Subjects: et al 2015: PLoS ONE, 10(8): e0136369. A Randomised Placebo-Controlled Trial. Taubel et al. PLoS One. 2016; Concentration-Effect Modeling Based 11(9):e0163020. Testimonials on Change From Baseline to Assess the Prolonging Effect of Drugs on QTc Together With an Estimate of the Circadian Time Recruitment Please know that it has been an I am very pleased with the Project Course. Ferber et al. J Clin Pharmacol, 2014, “ absolute pleasure collaborating with “ Management of both studies Benefits of a Single Versus Multicenter 54(12): 1400-6. you and that I am most appreciative of undertaken on behalf of (blank) and any Approach in Early-Phase Patient Studies; the key contributions RPL has made to future studies we have to outsource will Shortening of the QT Interval After A case of Multiple Sclerosis Patients. this project thus far. I hope I have the automatically be contracted to you.” Food Can Be Used to Demonstrate Assay Berelowitz et al. The Monitor 2011 ; 21-25. opportunity to work with RPL again in Sensitivity in Thorough QT Studies. Taubel Early Phase Japanese Bridging Studies; the very near future.” et al. J Clin Pharmacol, 2012; 52:1558-1565. We were impressed with Richmond Their Global Significance and What to Look “ Pharmacology’s professionalism and Insulin at normal physiological levels does for when Selecting a Suitable Contract We will again rely on your support, and knowledge base/experience with our not prolong QTc interval in thorough QT Research Organisation to Conduct these “ we have every confidence that you will study type as well as with Richmond’s studies performed in healthy volunteers. Studies. Berelowitz et al. International continue to provide the high level of willingness to discuss the safety aspects Taubel et al. Br J Clin Pharmacol 2012; Pharmaceutical Industry 3(1 ); 64-72. service that you have already done.” and study design of our protocol.” 75(2): 392-403. London City Airport

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1a Newcomen Street St George’s University Croydon University Hospital London Bridge London (Woodcroft Wing) London Cranmer Terrace 530 London Road SE1 1YR Tooting, London Croydon SW17 0RE CR7 7YE

Telephone: +44 (0) 20 7042 5808 Fax: +44 (0) 20 7378 9135 Email: [email protected]

Office Hours: Monday - Friday: 08h00 - 19h00 GMT Spoken Languages: English, French, German and Japanese