Rho puts experience to work for your organization
Clinical trials involve a myriad of complicated processes and variables. Rho can help you navigate the process with our clinical trial consulting services to save you time and minimize costs. Each client benefits from our years of expert support of the world’s leading pharmaceutical and biotechnology companies as well as the National Institutes of Health and other federal agencies.
Rho’s CRO pharmaceutical consulting services
We consider elements of the protocol and how they will shape the requirements for executing the clinical trial. We instill expertise into each protocol we craft, priding ourselves on enhancing the ease of execution, delivering the science, and taking site operations into account. Our efficient process ensures that your protocol is finished on or ahead of schedule.
Clinical regulatory support
Our clinical regulatory experts can serve as resources to 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 and guide the client through each step of the process: providing expert advice, planning meetings, preparing pre-meeting briefing packages, and facilitating communication with regulatory agencies.
Our highly qualified professionals can critique existing protocols or publications describing completed clinical trials. Our scientists develop simulations and conduct ad-hoc analyses to investigate underlying assumptions or study results. We can then package our results as responses to regulators' questions. Our statisticians design adaptive trials and confirm the approach with the FDA.
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.
NDA/BLA/PMA Gap Analysis
After achieving proof-of-concept in phase II, it is important to assess what will be needed to complete a marketing application, whether it be an NDA, BLA, or PMA. A gap analysis can help you look at what data already is available, what is needed, and how best to fill the gaps. Our experts have extensive experience bringing drugs, biologics, and devices to market and can help map a path to approval that makes the best use of the data already available.
Our experts understand a wide range of industry data standards and apply them to the needs of individual studies. Our skill at supporting and working with such a range of data standards maximizes our ability to meet our clients' goals.
We can help you find the right Rho expert to meet your needs
If the scientists who are designing your clinical trial program could benefit from Rho's clinical trial consulting and experience, contact us. We have the expertise to guide you in the right direction.
Rho’s CRO pharmaceutical consulting services include:
- Integrated product development
- Clinical operations and monitoring
- Project management
- Medical monitoring
- Product safety and pharmacovigilance
- Biostatistics and statistical programming
- Clinical data management
- Regulatory operations
- Data standards and CDISC
- Regulatory and medical writing
- Quality assurance