Clinical Trial Supplies
Clinigen – long a market leader in the sourcing and supply of quality assured commercial drugs for use as comparators and co medications in clinical trials – is now able to offer an equally agile, innovative approach to clinical trial packaging, labeling and distribution and biological sample management.
Operating from numerous GMP locations in the US, UK, EU and Asia Pacific Clinigen offers an end to end Clinical Trials Supply service with truly global reach and experience. Delivering the right medicine, to the right patient, at the right time!
IEC Imaging Core Lab team receive, analyse and report clinical trial images, including CT, MR, XR, PET, etc. and nuclear medicine images, in all therapeutics areas with strong focus in oncology and neurology.
We are proud of our Innovative Management strategy, focused in providing high quality data in alignment with ICH-GCP requirements and ensuring homogeneity within countries and sites.
We provide expert support in all stages: protocol review, design of the study imaging manual, site selection and validation, images acquisition and transfer, images QC, central reading and data export to customers. Timely and high quality central reading services!
Micron, Inc., the largest team of imaging experts in Asia, provides imaging core lab services such as central review, image analysis, and consultation services for the clinical development of medical products and medical devices.
Micron handles various studies such as oncology, central nervous system, cardiovascular, orthopedics, ophthalmology, dermatology, and other therapeutic areas along with numerous medical imaging techniques (CT, MRI, PET, SPECT, X-ray, medical photo, etc.).
By utilizing our vast expertise and experiences, Micron offers high quality and flexible services to sponsors throughout the Asia-Pacific region. Of course, our services meet international regulations and the latest guidelines.
Our imaging specialist team and our key opinion leaders from multiple fields are very confident in providing various kinds of high-quality, state-of-the-art services for your clinical trials.
Patient Support Programmes
Each manufacturer’s biopharmaceutical product and medical device is unique and so is each patient population. Product’s reputation relies on experienced, patient-centric services.
Non-adherence to medication is a frequent and widespread phenomenon, can be a major barrier for realising the benefits of medicines and is a significant barrier to the safe, effective and cost-effective use of medicines. Non-adherence is recognised as one of the major factors contributing to therapeutic partial or non-response. It is highly prevalent, associated with increased morbidity and mortality, costly to manage, and until recently a very much neglected aspect of prevention and treatment of illness.
Every medicinal product must satisfactorily complete a clinical trial and establish an acceptable evidence of safety and efficacy before being placed onto the market. This is why monitoring of the proper and safe conduct of clinical trials is central to the success of the medicinal product you wish to place on the market.
Pharmacovigilance in clinical trials helps in assurance of investigated drug’s safety through monitoring, detection, collection, assessment, and prevention of adverse effects. Marti Farm’s full support and knowhow covers everything from expedite SUSAR reporting to the regulatory authorities (within the EU and around the world), writing of narratives, causality assessments, DSURs, and case processing, to the preparation of signal detection reports and IND annual reports. Also, we have the knowledge and the ability to assist you in any of the 4 phases of the clinical studies. We offer a global, world-wide coverage of full safety monitoring services in both, clinical phase of the drug development and in post-market surveillance.
Our licensed pharmacists will ensure you meet regulatory requirements, and will help you to support patient safety and security.
We aim to ensure patient safety through diligence and scientific integrity by providing a wide range of pharmacovigilance services:
We are a Pharmacovigilance (PV) and Medical Information service provider for Latin America, giving support to our clients in 24 countries with end-to-end PV services and modules tailored made to our clients’ needs. We fully support all PV activities in clinical trials (SUSAR management, DSUR submission, special local periodic reports, etc.) as well as in post the marketing phase (LQPPV with local residence, ICSR management, Local Literature Screening, PV Intelligence, RMPs, PSURs, Audits, PV for orphan drugs/EAP/CUP/NPU). We work in strict adherence to local regulatory requirements and are focused on patient safety. Our company is the first company certified in ISO 9001:2015 for Pharmacovigilance Services in the region.
Patient Recruitment & Retention
CSSi provides full-service global patient recruitment and retention services. Each country will have its unique needs and challenges associated with enrollment. For each study we develop tools and services specifically for each country keeping in mind, cultural nuances, ethics approved recruitment/retention services, and past results.
Our Local Enrollment Specialist, former study coordinators, work with each site to ensure the customized recruitment plan is executed and metrics on all tactics are collected for the study team to make quick, informed decisions on recruitment. Localizing recruitment activities and centralizing data ensure optimal enrollment timelines. Patients are our focus!
If patient comfort and convenience is a must in your clinical study, we are the best choice. We bring the site visit to patients wherever they live, work, study or play. Our processes ensure the confidentiality of subjects’ identities. In-home nursing is led by a physician and a matron with clinical trial experience to deliver the highest standards in off-site clinical study visits.
Our home care services include:
Real World Data Collection
Real World Data (RWD) is data sourced from various medical environments and relates to patient care, clinical work, and research. When collected and used as structured information, it can expand our understanding of disease progression and safety and effectiveness of treatments with the speed and accuracy required by the health care environment and patients today. Considering the diversity of data sources and the complexity of clinical evidence, RWD collection has to be thoroughly organized, coordinated, and technologically supported, and standardized.
We at Wemedoo apply our clinical and data expertise and technological advantage to rapidly extract RDW for your clinical trial needs. Our RWD collection framework comprises of a complete ecosystem of expert services and software solutions dedicated to organizing and collecting data from various sources, such as electronic health records, disease registries, e-health devices, and even from past clinical trials and observational studies. Our approach has been carefully designed to provide our clients with valuable leverage in decision-making and accelerate the approval paths of medical products.
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