Phase 1 Experience

InFocus Clinical Research has a proven and committed group of phase I sites pre-qualified to execute your Phase I needs. Additionally, InFocus Clinical Research specializes in providing clinical study expertise for the management of your Phase 1 trials. Regardless of your Phase I study type: first time in human, a dose tolerance study, a food effect study, a Pharmacokinetic (PK) study or a Pharmacodynamic (PD) study, our experienced staff can work with you to ensure:

• The Phase 1 center and personnel are trained on conducting the trial.
• The appropriate regulatory documentation is collected and maintained.
• Clinical data are being collected using Good Clinical Practices.
• Adherence to study protocol.
• Safety data are being collected and reported to regulatory agencies.

Through our extensive Phase I experience, we have found that PK trials demand an additional level of expertise because of their uniqueness and complexity. In addition to the standard activities performed on other phase I studies such as verifying informed consent, protocol compliance, AE reporting, and investigational product handling, PK studies also require:

InFocus Clinical Research will provide monitoring services to ensure your Phase I study is being conducted according to the protocol and local regulations. To facilitate these services in a timely and cost-effective manner, our monitoring staff is located throughout the country near most Phase I facilities. This regionalized model, combined with our experience with and knowledge of the core ophthalmology phase I centers enables InFocus Clinical Research to quickly respond and provide results to our client needs.

InFocus Clinical Research always customizes solutions to our partners study specifications in to increase efficiency and productivity. The InFocus Clinical Research study team is directed by the InFocus Clinical Research project manager who becomes an extension of your internal team in order to make the communications link direct, concise, and effective.

Phase 4, IIS, Other Experience

Phase IV studies often focus on new claims once a drug has been improved, and every second matters in a competitive market. InFocus Clinical Research can expedite enrollment at key sites worldwide, align vendors and support groups, and keep sites and site staff engaged throughout the duration of these important trials to ensure proper deliverables and actionable results. Our success in these efforts rests in our ability to:

• Maintain monitoring and project management staff (less than 10% turnover)
• Develop strong Continuing Education Grant Programs for Sites and Staff
• Navigate regulatory filings, even globally, as necessary
• Remain flexibly in our approach and relationship with Reading Centers around the world
• Connect with Sites through our digital marketing and communications efforts
• Leverage our Best In Class eVision CTMS and eTMF platform

Or staff is located across the US near most major medical facilities and throughout the world in key markets. Being therapeutically focused, our staff have worked with most of your important investigational sites for years on dozens of protocols. As an added benefit to saving our clients money through native efficiency, this rapport and respect with your sites ensure greater commitment to your study, faster recruitment, and better responsiveness.

InFocus Clinical Research always customizes solutions to our partner’s study specifications in to increase efficiency and productivity. We provide our clients direct access to senior staff throughout the life of their project to ensure that any questions or issues related to the trial are addressed quickly.