Bio Soft Research provides global Clinical Development Services to support every step of the clinical development pathway, from first in man studies through registration studies as well as post approval programs.
Our aim is to help our clients strategically navigate through the various phases of clinical development to ensure the client creates a robust, innovative strategy to maximize asset value and the probability of success.
Clinical Development and Clinical Strategy consulting
Our expert clinical development team will partner with our client to create a Target Product Profile (TPP) which will serve as a solid foundation on which to guide clinical development in support of the targeted label indication, and improve communication to regulatory authorities.
Our blend of expertise in clinical, regulatory and clinical statistics understand that each of our clients have unique and different clinical development needs. Together this team looks at our clients milestones, end goals and through provision of innovative clinical development knowledge, create a clinical development program designed to gain both regulatory approval and achieve commercial success.
Bio Soft Research clinical development differentiator is our cross-functional and clinically focused team who provide innovative strategic and tactical solutions to optimize and de-risk drug development.
Custom Solutions for Every Study Challenge
As an industry-leading contract research organization (CRO) and functional service provider (FSP) for clinical trials, Advanced Clinical provides foresight and know-how that navigate even the most challenging studies.
Along with closely evaluating all aspects of your trial to proactively assess the best options for your study, our global contract research organization and functional service provider model offers clinical trials a highly collaborative environment and integrated approach that enable easy access to senior experts and resources from across the organization, improving the experience for all stakeholders.
Our CRO & FSP Clinical Trial Services
From feasibility assessment to study completion, we implement informed strategies that optimize trial effectiveness and patient centricity to provide a better clinical experience. With significant therapeutic expertise across a broad range of indications — including extensive experience in Oncology, Neurology, Diabetology, Cardiology, Gastroendocrinology etc.. — our organization provides range of high-quality contract research organization and functional service provider clinical trial solutions
Global Feasibility
Site Identification & Selection
Global Study Startup
Patient & Site Engagement
eTMF & Document Management
Clinical Monitoring
Hybrid & Decentralized Trial Solutions
Biostatistics and programming (SAS & R)
Medical Monitoring
Safety & Pharmacovigilance
Medical Writing
Quality Assurance
Clinical Data Management
Data Science
The FSP Model for Clinical Trials With 10+ Years of
Custom-Built Solutions
Advanced Clinical’s FSP clinical trial delivery model is powered by our team of experts to create functional solutions that are tailored to the specific requirements of your organization and clinical development strategy.
For a true functional service partnership, the combination of our deep understanding of your culture and organizational infrastructure with our industry insights and focus on innovation enables us to build solutions customized to your strategic business requirements.
Our organizational stability allows us to attract and retain the best clinical research professionals, enhancing collective team knowledge, and our active oversight and engagement with your functional team enables us to identify potential issues proactively and build solutions to quickly address and resolve them.
Our best-in-class resourcing engine gives us access to top global talent, and our comprehensive tools and data platforms provide market data and practical insights to support functional services and address your specific clinical trial challenges.