ObelysQ is a leading quality assurance consulting firm offering tailored solutions to the pharma industry aiming at enhancing compliance and improving processes in the execution of clinical trials. Our Headquarters are in Neuchâtel, with a branch in Poland and one being opened in the USA. With 50+ quality experts, we provide quality assurance and data privacy services all around the globe. GCP/GVP Consulting ObelysQ can provide support in the form of remote consulting done on an as-needed basis or simply be present there on your premises for the time you deem necessary. Together, we can discuss and evaluate the parameters of your project and further decide on what would be the best approach to support your endeavors. We do not believe in a one-size fits all solution and value the partnership and collaboration with our clients. GxP auditing ObelysQ can help you having meaningful and impactful audits. At an early stage, we can help you establish an audit strategy which will ensure an efficient use of your resources. You can also ask ObelysQ to conduct the audits on your behalf, our team has experience with various types of indications, dosage forms, vendors, and systems, and this on all continents! QMS set-up We will create tailored standard operating procedures that are compliant with the regulations, pragmatic enough to allow your staff to consistently and efficiently perform their duties, and adapted to your organization’s size and structure. With experience of developing SOPs for numerous sponsors and CROs, ObelysQ will build your SOPs from scratch or update your existing SOPs to optimize timelines, compliance, adherence and efficiency. Health Authority Inspection Bringing experience in successfully managing dozens of sponsor and site inspections (FDA, MHRA, EMA, CFDA, etc…), ObelysQ will provide your organization with an efficient and collaborative management of all Competent Authorities GCP inspections to maximize the chance of a successful outcome, while engaging your staff and decreasing anxiety. Our collaboration will include the development of a specific inspection plan, evaluation of the risks and potential issues in every aspect of your program/study, communication with all relevant staff, training, interview coaching, set up of the inspections facilities, inspection hosting and/or back room support, development or responses to inspection findings. You can pick and choose depending on your needs and the nature of the inspection. Training In order to provide the best in class GCP/GVP training, we develop and adapt out training material based on your specific needs, regulations and their updates, business best practices and inspection findings. You decide the approach that fits your needs best as we offer all solutions: presenting GCP at Investigator meetings, conducting face to face training sessions, providing online training tailored to your type of project. Gap Analysis ObelysQ will conduct a full clinical gap analysis to assess your staff, facilities, processes, documents and data. You will receive a detailed report with pragmatic recommendations tailored to your organization to strengthen your clinical processes and ensure GCP compliance and inspection readiness. ObelysQ will also support their implementation and conduct an effectiveness check to ensure objectives were met. You can decide to focus on the entire clinical organization or on a single unit such as your Clinical Qualtiy Unit. We’ll identify all areas for improvement to ensure you have best-in-class Clinical Quality structure and processes. Data Protection Support ObelysQ can help increase compliance through a series of distinct services that allows our clients to ensure their staff is adequately informed of important data protection concepts and regulations. -Data protection training (on-site or e-learning) -Data protection (GDPR) gap analysis -Development of data protjection strategies, SOPs and tools -Externalized Data Protection Oficer(DPO) specifically for clinical trials -GDPR-compliance assessment of vendors.
NZCR – Optimal Clinical Trials
All-Phase Clinical Trials Group Delivering Speed And Scale: We’re New Zealand’s all-phase clinical trials leaders, delivering at speed and scale so better treatments reach those who need them sooner. With deep expertise, experienced investigators, and efficient processes, we keep your study moving forward. * Part of NZCR Group – Australasia’s largest clinical trials group offering complete Phase 1–4 capability (NZCR leaders in early phase, Optimal in late phase research) * Broad therapeutic specialisations with around 1,000 research professionals * Frequent highest recruiter globally/APAC/ANZ, frequently achieves first-participant-in, proven rescue site capability * Access to around 75% of New Zealand’s primary care database, a diverse patient pool of over 153,000 and high trust in clinical research * Quality data, ISO 9001 certification, FDA audit success, average NPS of 97 from sponsors and CROs and 95-100% participant retention * Government-approved RDTI provider
Novotech
Novotech is a globally recognized full-service clinical research organization (CRO) and scientific advisory company that provides biotech and small- to mid-sized pharma companies an accelerated path to market since 1997. With a global footprint spanning 30+ offices across the Asia-Pacific region, North America, and Europe, and partnerships with 5,000+ trial sites, Novotech offers unparalleled access to key clinical trial destinations and diverse patient populations. Novotech leverages its therapeutic and regulatory expertise, client-centric service model, local market insights, and advanced analytical tools to expedite patient recruitment, enhance trial efficiencies, and bring life-changing therapies to market faster. This work has been recognized by awards such as the Frost & Sullivan CRO Company of the Year, which Novotech has received for 19 consecutive years.
MEDIAIPLUS, Inc.
MEDIAIPLUS address major bottlenecks in the clinical trial process by leveraging the world’s largest clinical trial dataset and advanced AI technology. Our two flagship solutions are: – MediC: A subscription-based platform offering real-time access to over 720,000 clinical trial reports, patents, regulations, and guidelines. – FiCRO: An AI-powered matching engine that connects sponsors with the most suitable CROs based on 20+ data points, including past performance history and RFP criteria. MEDIAIPLUS is trusted by global stakeholders in pharmaceutical, biotech, and medical device industries for accelerating clinical trial efficiency and decision-making. | “Create a virtuous cycle in clinical trials to provide more treatment opportunities for patients.” MEDIAIPLUS provides innovative solutions to help pharmaceutical, biotech, and medical device companies conduct clinical trials more efficiently. To address bottlenecks in the clinical trial process, we have built the world’s largest clinical trial dataset and leverage AI to generate groundbreaking insights. To achieve this, MEDIAIPLUS offers two key solutions. MediC is a subscription-based service that provides real-time access to a vast database of clinical trial reports, patents, regulations, and guidelines. FiCRO is an AI-driven solution that matches sponsors with the most suitable CROs for their specific clinical trials based on RFPs. MEDIAIPLUS’ AI-powered innovations in clinical trials have gained significant attention and recognition from key players in global clinical research. | MEDIAIPLUS offers solutions to significantly reduce the time and cost of clinical trial preparation. We hold the largest clinical trial dataset in the world and leverage AI to help researchers prepare for clinical trials. Through our solutions, we tackle bottlenecks in trials and create more treatment opportunities for patients.
LSK Global PS
LSK Global PS delivers a comprehensive, end-to-end clinical development model built on 26 years of industry experience, aligning strategy, operations, data, and regulatory functions to minimize delays, reduce risk, and ensure quality. Unified workflows across clinical operations, data management, and biostatistics enable efficient execution and timely submissions, while pharmacovigilance and medical writing are seamlessly incorporated to support submission-ready deliverables. Combined with academic and epidemiological expertise and extensive domestic and global trial experience, this approach strengthens regulatory readiness and supports successful clinical development in Korea.
Harvest Integrated Research Organization (HiRO)
HiRO is a modern global CRO delivering full-service clinical trial support across ANZ (for over 25 years), APAC, US, and Europe. We combine global infrastructure with genuine local expertise, offering sponsors the agility and personalization that larger organizations can’t match, without sacrificing rigor or reach. From regulatory strategy, clinical operation support and management, site identification and management, biometrics, pharmacovigilance and medical monitoring, HiRO accelerates the path from discovery to patients. Highlights ⦁ Modern local CRO operating across ANZ, APAC, US, and Europe ⦁ Full-service: clinical design, regulatory, biometrics, safety, and monitoring ⦁ Global expertise paired with hands-on regional insight ⦁ Agile operations built for faster, cleaner clinical data ⦁ True partnership model, embedded in your team from day one | Harvest Integrated Research Organization (HiRO) is a globally oriented, innovative clinical research organization (CRO). With global operations and integrated capabilities, HiRO provides a full range of cross-border solutions and services to its clients, including early pre-clinical strategic planning, clinical trial design, regulatory affairs, pharmacovigilance, statistics, data management, end-to-end project management, and clinical and medical monitoring services. As an emerging global CRO, HiRO strives to become a market-leading, integrated global clinical research organization that works collaboratively with biotech and pharmaceutical companies to bring new products from the laboratory to the market, providing more effective solutions for patients worldwide.
GlobalData
GlobalData has decades of experience in being the trusted, gold standard intelligence provider to leading Pharmaceutical brands, manufacturers, and suppliers, helping them to make faster, more informed decisions. | GlobalData is a data and analytics company providing the Life Science Community with Market and Competitive Intelligence. GlobalData serves over 4,000 world’s largest companies with over 600 healthcare analysts by gaining insights into competitors, evaluating market opportunities, and provide strategic opinions in the Pharma/Biotech, CMO/CDMO, CRO, Medical Device/Medtech and Consumer Health industries. From research and development, clinical trials, business developments to investment due diligence, our clients can make better business decisions on our fully integrated one-stop intelligence center platform. | GlobalData’s Construction portfolio offers insights across the entire global construction market, from market-sizing, companies, construction innovations, risks, regulatory developments, M&A, and financial transactions, to projects and project contacts. Our connected Construction Intelligence offers the most comprehensive coverage of construction projects available, tracking new construction projects totaling over US$70tn globally from announcement to completion, by sector, stage, scope, and more. Our industry leading portfolio of brands include Cranes Today, Tunnels & Tunnelling, and World Construction Network amongst others, and have informed the construction landscape since 1969.
FGK Clinical Research GmbH
FGK provides full service for clinical studies to biotechnology, medical device and pharmaceutical companies. FGK has the right size to handle international multi-center studies with hundreds of patients or single country studies with a few patients, but is still small enough to guarantee a personal service to the sponsor. With our more than 200 highly qualified medical, scientific and regulatory experts, we have all knowledge and experience necessary to succeed in Europe and can guide you through the clinical trial process, from planning and approval to the final report. Full service or partial services for conduct of clinical trials including: * clinical trial management and clinical monitoring * regulatory submissions * biostatistics * data management * eSolutions * medical writing * medical safety * quality assurance * pharmacovigilance * consulting services FGK also offers legal representation services for sponsor companies conducting trials in the EU without having a subsidiary there. | FGK is a European, owner-managed Clinical Research Organization providing full service for clinical studies to biotechnology, medical device and pharmaceutical companies. FGK has the right size to handle international multi-center studies with hundreds of patients or single country studies with a few patients, but is still small enough to guarantee a personal service to the sponsor. With our 240 highly qualified medical, scientific and regulatory experts in the EU and the UK, we have all knowledge and experience necessary to succeed in Europe and can guide you through the clinical trial process, from planning and approval to the final report. Full service or partial services for conduct of clinical trials including: ▷ clinical trial management and clinical monitoring ▷ regulatory submissions ▷ biostatistics ▷ data management ▷ eSolutions ▷ medical writing ▷ medical safety ▷ quality assurance ▷ pharmacovigilance ▷ consulting services; — FGK also offers legal representation services for sponsor companies conducting trials in the EU without having a subsidiary there (www.fgk-rs.com) and post-market pharmacovigilance services (www.fgk-pv.com).— | FGK Clinical Research GmbH is a full service Contract Research Organization with offices in Germany (HQ), Poland, Czech Republic, Hungary, UK and US. We provide full service for Phase I – IV clinical studies. Our international client base includes biotechnology, medical device, and pharmaceutical companies. FGK has the right size to handle multi-country, multi-center studies with hundreds of patients or single country studies with a few patients, but is still small enough to guarantee a personal service to the sponsor. With our about 240+ highly qualified medical, scientific and regulatory experts, we have all the knowledge and experience necessary to succeed and can guide you through the clinical trial process, from planning and approval to the final report. | FGK is a CRO, offering full service for conduct of clinical trials in all phases, specialized on biotech and medical device companies. Founded in 2002, owner-managed structure, guaranteeing a personal and flexible approach to our clients. FGK has the right size to handle international multi-center studies with hundreds of patients or single country studies with a few patients but is still small enough to guarantee a personal service to the sponsor. With our 240 highly qualified medical, scientific and regulatory experts, we have all knowledge and experience necessary to succeed in Europe and can guide you through the clinical trial process, from planning and approval to the final report. Full service or partial services for conduct of clinical trials including: * clinical trial management and clinical monitoring * regulatory submissions * biostatistics * data management * eSolutions * medical writing * medical safety * quality assurance * pharmacovigilance * consulting services
EPS Group
From our beginnings in 1991 as a systems company built on medical statistics, the EPS Group has responded to customer needs amid structural changes in the market and increasingly rigorous and complex drug development. EPS has evolved as a CRO (Contract Research Organization) and expanded our offerings to include SMO (Site Management Organization) and CSO (Contract Sales Organization) services, thereby becoming a comprehensive provider of various support services for the healthcare industry. CRO： In response to requests from pharmaceutical, medical device and regenerative medicine companies, medical institutions, governmental agencies, and others, the EPS CRO Group provides One-Stop Solutions to support the development of pharmaceuticals, medical devices, foods, and cosmetics. SMO： The EPS SMO Group enhances clinical trials by collaboration with medical institutions across Japan, leveraging digital technology to improve efficiency, including the promotion of Decentralized Clinical Trials (DCTs) and the development of remote systems for clinical trial document management. CSO： The EPS CSO provides targeted support to pharmaceutical and medical device manufacturers after product approval. We provide contact center operations, and a range of services from pre-approval to post-marketing stages, employing a skilled workforce to effectively fulfill customer needs. | EPS Holdings, Inc., a Japanese headquartered company, is a comprehensive provider of clinical trial and research outsourced services. EPS Group, with over 7,800 staff, provides quality support to pharmaceutical, biotech, regenerative medicine, and medical device companies. Core businesses are CRO, SMO, Contract Sales Support, and China product development and distribution. EPS operates in Japan, China, South Korea, and Taiwan and, through a partner, supports studies in other Asia-Pacific countries. Looking towards the future, we will strengthen our forward-looking spirit expressed as an “Ever Progressing System.” | The EPS Group was founded in 1991 as a pioneer in the domestic Contract Research Organization (CRO) industry. Since then, we have expanded our diverse services, including Site Management Organization (SMO) and Contract Sales Organization (CSO), with a primary focus on CRO. We provide end-to-end support solutions from the development of pharmaceuticals, medical devices, and regenerative medicine products to post-marketing surveillance. Building on the foundation of our clinical trial and post-marketing businesses, which boast a top-tier scale and proven track record in Japan, we are actively engaging in data business and new ventures, constantly striving for evolution.
Dasher Neuroscience Inc.
Dasher Neuroscience is dedicated to pioneering research in central nervous system (CNS) diseases. By integrating artificial intelligence (AI) technology, Dasher Neuroscience aims to drive groundbreaking advances, offering innovative treatment options for patients worldwide.