Clinical and pharmacovigilance outsourcing
Client requirements in clinical research outsourcing vary from small projects to end-to-end studies – as large pharmaceuticals and mid-tier life sciences companies warrant the same attention and quality commitment from service providers.
Infosys-Ecron Acunova (EA) partnership realizes that small projects and low budgets refer to high stakes in clinical research. Our unique delivery model ensures project success through flexible and scalable solutions. Whether the need is medical / scientific expertise for protocol design, implementation of a clinical data management system, or adverse event call centers, we have the solutions.
Our end-to-end service offering comprises regulatory consulting, IP import and sample export, protocol design, ethics committee submissions, safety screening, and bio-analytical testing. In addition, we are experts in clinical study management, method development and validation, data management with Oracle Clinical, PK analysis using WinNonlin, statistical analysis using an SAS, and report writing.
Our partnership blends the focus and specialization of a boutique CRO with the resources of a large services firm. We provide domain knowledge, patient access, technology services, and financial strength to pharma and biotech companies. With Infosys and EA, clients no longer have to compromise on quality for speed. Our team of medical and regulatory professionals accelerates time-to-market in compliance with Food and Drug Administration (FDA), European Medicines Agency, and other international regulations.
- We provide custom solutions that scale from individual resources to global outsourcing of entire projects or operations.
- We have the ability to deliver internal technology solutions and / or hosted based on client need.
- We can rescue projects that fail or are in jeopardy due to lack of resources.
- Our medical and regulatory expertise in technology infrastructure improves quality and ensures on-time delivery of projects.
- Our Global Delivery Model ensures efficient service from qualified medical and regulatory professionals.
- We offer a variable or value-based pricing model.
- In New Engagement Models (NEM), our price is a direct reflection of customer's business priorities and business outcomes and value realization from Infosys IP.
- Augmentation of an existing team helps clients avoid the need to halt and re-initiate studies owing to loss of staff or partner.
- Increased continuity of studies / projects ramp up ensures accelerated timelines for new services.
- Increased quality in projects results in lesser rework and greater detail, ensuring regulatory compliance.
- Clients can maintain or improve quality and accuracy of services and reduce R&D costs.
- Combined with faster throughput, clients realize faster time-to-market, maximizing patent life, and profitability.