Post Approval Studies
At VST Research, our understanding of the complex post-approval environment combined with decades of experience in product developmenttranslate into a proven ability to deliver effective study designs that are tailored to meet clients’ specific objectives, marketplace needs and regulatory requirements. Our late stage experts work closely with you to develop creative, flexible solutions to help you realize your product’s greatest value.
Centralized systems and processes give VST Research the ability to design simple but effective post approval trials with experienced investigators. Dedicated project teams create comprehensive solutions specific to your requirements, including accelerated trial start-up, rapid investigator and patient recruitment, and efficient analysis and reporting of clinical data.
VST Research delivers essential knowledge about drug use and treatment outcomes in real-world clinical practice through our post-approval patient registries. Our epidemiology, operations, safety and therapeutic experts design and implement the ideal study to meet market challenges successfully and to collect the data you need to demonstrate your product’s true value.
Our Post-approval research services include:
- Phase IV studies
- Expanded access programs/named patient programs
- Post-approval studies
- Investigator-initiated studies
- Observational and epidemiological studies
- Pharmacoeconomics and health outcomes studies
- Registries (all types including patient, disease, product and pregnancy)
- Research to support risk evaluation and mitigation strategies (REMS) and risk management plans
- Post-authorization safety studies (PASS)
- Large simple trials
VST Research Consulting
Focused feasibility review
We have a diverse team of experts, ranging from local clinical research associates as well as key opinion leaders, who can conduct or review feasibility studies. Our aim is to conduct feasibility studies which are realistic and should have a success rate of over 80%. We focus on all areas of a clinical project rather than focusing only on patient population thereby significantly increasing the chances of success.
Clinical trial documents
Whether you need input at concept, synopsis or into final protocol we can provide it all. We have experts who can provide an ethical and practical approach of the study conduct to minimize protocol amendments and changes in other key study documents. We can also organize an informal feedback from regulatory authorities.
Stress testing of Clinical strategy
By using simulation models we can predict the chances of success. We can devise a fully personalized communication plan, based on the needs and wants of individual stakeholders. By critically reviewing the projects we can advise of saving costs. We have been able to save approximately 15% of total costs for our clients in the past.
Targeted Data review
Poor data quality is one of the major concerns both for sponsors as well as Regulatory authorities. We offer a comprehensive data cleansing service targeting both Efficacy as well as Safety. Our team has the capacity and experience to perform a 100% data review in limited time. We have successfully reviewed over 50 large phase III clinical trials data
Bridging the gap
Trend for outsourcing is increasing and numbers of FTEs per projects are decreasing. Rush to initiate projects is a leading cause for inadequate definition of vendor’s scope of work. We can act as a bridge between Sponsor and Vendor. Our teams have vast experience of working with Sponsors as well as CROs and hence will be able to spot any deficiencies in the scope and can facilitate ongoing vendor management services. We also critically analyse the business need before searching for vendor and perform a thorough due diligence process before vendor selection.