Clinical Trial Supplies
With the acquisition of CSM in 2018, 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!
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.
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
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