Clinical innovation and technology begins with leveraging cutting-edge tools, strategies, and partnerships to ensure that the highest quality clinical trials are conducted with speed and agility. Patient engagement, collaboration, and accurate data produce reliable results to deliver new medicines to the public quickly and efficiently.
Information technology has become an essential part of healthcare, as physicians, patients, insurers, regulators, and operational personnel alike rely more on access to data and medical systems. With regulations mandating electronic health records and increased accountability, it becomes more important than ever to make sure that your systems and processes meet the standards.
With an extensive background in electronic health records technology and two decades of experience to draw on, Innovative Development consultants are intimately familiar with what’s required to meet mandates and create useful clinical information systems for caregivers and pharmaceutical organizations.
Innovative Development has a clear understanding of clinical application roll-out, clinical trial management, data analysis, contract services, document management systems, infrastructure assessment, revenue cycles, ICD-10 readiness, and medical coding among others. Our consultants assess your specific situation and consider anticipated requirements for program compliance, data management, capacity, as well as your available resources and existing capabilities.
Innovative Developments’ clinical solutions can help your organization develop, expand and direct the process by supporting your clinical resourcing needs – whether you require one person or a project team. By closely managing resources deadlines are met while reducing costs.
Our consultants understand industry data standards and apply them to the needs of individual studies.
We engineer our client’s protocols to ensure requirements are identified ensuring quality is built into executing the trial. Our protocol design emphasizes ease of execution, delivering quality results, while accounting for site operations.
Clinical regulatory support
Our clinical regulatory consultants will create protocols that can be finalized quickly and supported by sites so that studies run on time or even ahead of schedule. We provide investigational new drug (IND) and new drug application (NDA) support. At each step of the process we can provide: expert advice, planning meetings, preparing pre-meeting briefing packages, and facilitating communication with regulatory agencies.
Just ask and our experts will critique existing protocols or publications describing completed clinical studies. Our consultants assist in the development of simulations and conduct ad-hoc analyses to investigate underlying assumptions or study results.
Submissions regulatory support
We can also provide our clients with comprehensive and integrated strategic regulatory consulting and submission services from early phase development through post-marketing activities, including life cycle management of pharmaceuticals, biologics, and devices.