we EXCEL FOR EXCELLENCE Clinical Research Technology Resourcing

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1 AssAY we EXCEL FOR EXCELLENCE Clinical Research Technology Resourcing

2 Contents About Us Clinical Research Phase I (Early Phase) Phase II/III Phase IV (Late Phase) Regulatory Clinical Monitoring Therapeutic Expertise Quality Assurance Technology Resourcing V-Share Global Reach Contact Us

3 About us ASSAY Clinical Research Limited is a UK based Clinical Research Organization which has evolved to be a trusted global service provider of innovative solutions for management of clinical trials for pharmaceutical, biotechnology, medical device industries and other CROs who are looking for experienced and professional team. We Listen To your needs We Understand Your requirements We Plan To your budget and timelines We Analyse The risk factors We Execute To your satisfaction We Oversee The quality WE ARE HERE For YOU

4 Clinical Research Drug development is one of the most challenging processes in this world in every aspect right from discovery of a molecule until post marketing. It requires and deserves every attention one can give as every drug is developed with a disease in mind which eventually has a potential to cure or prevent one or thousands of patients. We understand that attempts should be made to accelerate the entire process keeping in mind the time, cost and quality involved. To do this, you need the experts and we are there for you. Our base, presence and reach in the globe, our experienced experts and our vast therapeutic knowledge will make us your perfect partner for managing your clinical trials and deliver high quality outcomes at affordable costs within the timelines. Our services are tailormade and available for small to large organizations, single project to multiple projects, from single country to multinational studies. Phase I (Early Phase) Being the start of its journey, we understand that a molecule at this phase requires its most attention to make it a potential and safe option for further clinical studies and eventually for patient or human use. With our expertise in handling various types of studies, experience in a wide range of therapeutic area, our ability to handle different dosage forms and complicated protocols enables us to provide innovative and quality solutions to your studies. Our services for phase I trials includes designing and managing of First in man studies, Proof of concept studies, Bioavailability and Bioequivalent studies, Drug interaction studies, Dose escalation studies, safety studies and special population studies. We will be assigning a dedicated team headed by a project manager, all of whom will be experienced in handling your requirements along with the therapeutic knowledge required. The team will be accessible to you anywhere, anytime which will allow establishing good communication, robust planning and minimising risks in the most time and cost efficient manner. After all, patient safety is achieved through protocol compliance and our working model will ensure that this is achieved with highest quality standards including GLP, ICH, GCP and all other local regulatory guidelines. ASSAY with its technologies and expertise will assist you through every step of your trial. We will excel for achieving excellence.

5 Phase II/III Due to the sheer size and complexity of phase II and III trials in terms of recruitment, duration of the study and the costs involved, it is important that the most experienced and trained resources are available in order to obtain the most accurate results. At ASSAY, we have the ability to get connected to the perfect resources and expertise throughout the globe which will ensure that clients / sponsors are provided customized plans to execute their clinical trials successfully within the timelines and budget and with high quality standards. Phase IV (Late Phase) A safe journey from development to commercialization is vital to make the drug reach out to the humanity. ASSAY with its trusted partners will successfully conduct post marketing studiesthrough our strong therapeutic expertise, good documentation and effective communication. ASSAY will strive to assist our sponsors in the post-approval process in a cost effective manner within the expected timelines. We will excel for achieving excellence. We offer Clinical monitoring, Data Management, Project Management, Investigator Recruitment and site management, Protocol and CRF designing, Patient Reported Outcome management, Feasibility studies, Interactive technologies and any other customized services as required by the clients or project. ASSAY is committed to patient safety, ethics, quality and paramount client service. We will excel for achieving excellence.

6 Regulatory Clinical Trial set-up is the first and most crucial step towards successfully conducting the trial for the given duration. With stringent regulations in every region and country and its ever changing requirements, it is important to choose the right partner to start off the regulatory submissions which will ensure that all the requirements are taken care off by the right and experienced people. process for central regulatory agencies, local regulatory authorities (country and site specific) and license management (import and export licenses) throughout the duration of the trial. Our commitment to ethical standards and adherence to regulatory guidelines will ensure that our sponsors receive the correct consultation and assistance in every step of the regulatory submission. We will excel for achieving excellence. At ASSAY, our team of experienced professionals who are trained and constantly updated with the regulatory requirement of each country, will be able to assist you throughout the submission Clinical Monitoring As soon as a protocol is finalized and ready to be introduced to potential investigators who would facilitate in conducting the trial, the clinical monitoring team gears up to be in the front line between the study site and the sponsors. Their crucial role in maintaining the safety and efficacy of the trial and to maintain ethics and quality calls for a team of most experienced and trained. ASSAY will assist you through this. At ASSAY, we identify clinical monitors who are experienced in the therapeutic area and are experts in supporting the site staff and in maintain high levels of communication skills. Our extensive training programs for our monitors ensures that we are able to deliver quality performance well within the timelines and costs. Our Clinical Monitoring Services are tailor made to your needs. It can range from study plan development, Site and supply management, Regulatory documentation management, AE and SAE management, Source document review etc. We will serve as a clean and transparent window which will ensure open communication and lead to the success of the clinical trial in every aspect. We will excel for achieving excellence. Therapeutic Expertise Irrespective of the size of the trial, it is vital to be experts in the therapeutic area of the trial which will become a strong platform on which the clinical trial can be planned and executed successfully. At ASSAY, we have teams dedicated to each therapeutic area and our specialized resources will ensure that your clinical trial is given the right attention in every aspect. Our therapeutic expertise is across Oncology, Cardiovascular, Rheumatology, Rare diseases, Gasteroentrology, Infectious diseases, Vaccine studies, Pain management, Pediatrics, Central Nervous System and many more. It is our responsibility to ensure that your clinical trial is handled only by the experienced and experts. We will excel for achieving excellence.

7 Quality Assurance Quality is prime for any clinical trial and its related process as the intervention which is being put to test should prove to be safe for treatment or prevention or cure and also should comply with the ethical principles. To ensure quality, we require expert auditors who not only assure quality but also assist in enhancing the quality in a clinical trial. Our expert team of auditors will serve as an epicentre for your clinical trial and will assess every step of conducting the trial at site level, CRO level, technologies and vendors. Our team of experts are experienced in conducting audits in various regions under different regulations including the FDA, MHRA, EMEA and DCGIfollowing GCP, GLP and GMP guidelines. Our compliance with regulations ensures that our clinical trials are also compliant. We will excel for achieving excellence.

8 Technology This world is surrounded and driven by technology. A combination of technology and human intelligence is what ASSAY focuses on to deliver safe and effective results. GRAVITY is our dedicated site and central trial file management system which synchronises between trials files from various locations making document access, safe, easy, efficient and global. It is also an integrated safety management system where in all the AE, SAE and SUSAR documentation can be stored, managed and analysed effectively. CREATIVE is our technology to get connected within the study. It is a platform where the sponsors, CRO team and site team can stay in touch with each other and obtain instantaneous study updates. It is a window through which everyone in the team can see the bigger picture of the clinical trial and initiate various discussions and articles and share ideas. CliniCAL is our android app containing a combination of calculators which can be used by our clinical monitoring team during their site support activities and visits. The most unique of them all is our drug compliance calculator and visit window calculator which has everyday usage in any clinical trial. We are exploring further options on partnership for technologies as we believe that through technology we can speed up the processes in conducting clinical trials along with maintaining safety, ethics and quality. We will excel for achieving excellence.

9 Resourcing V-share Change is constant in this world and every change brings new challenges. Drug development in pharmaceutical / biotechnology / medical device industries being crucial on its own is influenced by these changes and challenges which in turn affects the time and costs involved along with a compromise on quality. Investments involved in handling these challenges also incur huge costs which becomes a challenge in itself. One among these challenges is resourcing. Hence you now need a perfect partner for all your resourcing challenges where the partner is able to offer effective solutions for staffing and managing resources based exactly to your needs. V-Share in clinical research industry will be able to out-source you an individual or a team of professionals to assist you with a part of your project or the entire project, full-time or part-time, anywhere across UK, Europe, Asia and West Africa. A key struggle faced by most organizations is spending too much time on small and routine tasks while conducting clinical trials. Compounding this problem is the cost and employee factor. V-share helps pharmaceutical / medical device / Clinical Research Organizations to overcome such challenges in a time and cost effective manner. We will be one among you and accomplish the tasks given to us. The tasks can range from one single activity to a combination of multiple tasks with flexible FTEs. With V-share you can hire for a specific task where we can act as your in-house team. Or we can identify the best candidate for your project needs and also provide line management solutions to ease out your commitments.

10 Global Reach Direct Operations UK, Ireland, Europe, India, Sierra Leone Operations through our preferred partners USA, Latin America, Sri Lanka, Bangladesh, Singapore, Malaysia, Thailand, Philippines, Australia, Russia.

11 AssAY Contact Us We are sure by now you have started thinking ASSAY for your project. Then please get in touch with us through one of the below methods and we will be happy to assist you. w w.facebo k.com/as AYCR/