With our collective experience working in early phase research and extensive expertise along the phases of drug development and post authorization, we can provide
guidance on what is required, when, and how you can get there.
Given the dynamic nature of Early Phase Drug Development, we can provide creative and adaptive solutions to match the evolution of your program. This adaptability
and critical thinking comes with a highly experienced skill-set that we, as your partner, can bring to your pipeline development.
Clinfinite Solutions maximizes clinical development solutions efficiencies across the globe, providing scalable, end-to-end service capabilities. With a cumulative 25+ years’ experience, our expertise has supported preclinical and clinical communities, helping streamline the clinical trial lifecycle. Our teams fully embed into workflows, providing expertise and in-depth knowledge from supply chain specialists to GxP and regulatory compliance trained project managers. Our portfolio of custom kitting, equipment & ancillary solutions, and biorepository & archiving services stands at the ready to serve any trial, be it proof of concept, investigator-initiated studies or clinical/device trials of any phase and size, anywhere in the world. Clinfinite Solutions your trusted partner, supporting over 100+ clinical trials around the globe. Our quality, choice, expertise, customization, and convenience propel clinical research. With our responsive, expert teams ensuring you have everything you need, when and where you need it, rely on our end-to-end capabilities to optimize your clinical trial.
Clinfinite Solutions provides regulatory consulting services across the globe for BioPharma
and MedTech companies in the following areas.
Regulatory Affairs – Local, Regional & Global support
Regulatory Operations
Life Cycle Maintenance
CMC – Clinical & Non-clinical
Commercialization Support
Clinfinite Solutions has experienced site management team across all phases of clinical
trials and can collaborate to support Local Regional & Global clinical studies with sites. We aid in strategizing & planning for risks and
mitigations to improve Project/ Program outcomes.
To achieve this, we utilize integrated or stand-alone solutions (requirement/ scenario based) which address infrastructure requirements and
operational dependencies between evidence-based quality medical care and clinical team operational processes.
Biotech
Pharma
Medical Devices
Nutraceuticals (Food & Nutrition)
Consumer Health
Clinfinite Solutions offers a range of project management services including site management,
construction management, project scheduling, and cost control. Our team of experienced professionals has a deep understanding of project management principles
and practices, which allows them to provide customized solutions that meet the specific needs of each client.
Their site management services include managing and coordinating all aspects of a project site, from logistics and safety to quality control and subcontractor
management. They also provide construction management services that involve overseeing the entire construction process, from the design phase to project
completion.
Clinfinite Solutions specializes in providing biometrics services for Lifesciences companies across the globe. With the increasing amount of data generated by companies, it has become essential to analyze and manage it effectively to gain insights and make informed decisions. Clinfinite manages and stores data securely to ensure its integrity and availability using advanced technologies and best practices to handle data in a secure and efficient manner. This can help businesses comply with data privacy regulations and prevent data breaches.
Clinfinite Solutions offers data management services through out the study start-up, conduct and close-out phases along with Electronic Data Capture (EDC) applications.
CDISC (Clinical Data Interchange Standards Consortium) standards form the many oceans and
seas of the research world, and mastery requires nothing less than years of navigation. Clinfinite offers support with CDASH (Clinical Data
Acquisition Standards Harmonization)
SDTM (Study Data Tabulation Model)
ODM-XML (Operational Data Model)
ADaM (Analysis Data Model)
Clinfinite Solutions provides biostatistics services for pre-clinical, clinical, late phase and post-marketing studies.
Clinfinite Solutions provides medical writing services for life sciences companies across the globe. Our writing areas include:
Regulatory
Clinical / Device
Safety
Scientific
Clinfinite Solutions offers the scale and flexibility to manage biospecimen and biorepository requirements globally for research and clinical trials. With a comprehensive suite of services, they enable efficient collection, processing, storage, and tracking of bio-specimens throughout their lifecycle. Clinfinite Solutions employ advanced technology and robust infrastructure, ensuring sample integrity and regulatory compliance. The platform incorporates sophisticated data management tools, facilitating seamless integration with electronic health records and supporting efficient data mining. Clinfinite Solutions empower researchers with secure and streamlined access to high-quality biospecimens, accelerating medical breakthroughs and enhancing personalized medicine. Their expertise and dedication make them a trusted partner for institutions and organizations in the field of biobanking.