PRE CLINICAL
We offer assistance in creating, and developing tailor-made studies or improving existing investigations to provide pre-clinical data for submission : IDE, IND, or 510(K). We combine professional training, prior hands-on laboratory and management experience with a knowledge of FDA requirements. This can significantly minimize costs and redkulce the time reqluired for product development.
Examples of projects that benefited markedly from Dr MacKeen's multi-disciplinary background
An in vivo study of hydrophilic contact lens uptake of chlorhexidine from a disinfecting lens solution devised by Dr MacKeen , who worked on the study with the ophtthalmology department at Medical College of Georgia. The results enabled FDA approval of the first non-thermal contact lens disinfection solutions . FDA guidance documents recommended his method for assessing chlorhexidine uptake by contact lenses for decades.
His experience with lasers and his ability to read scientific German facilitated the submission and subsequent approval of several medical lasers.
His work with FDA, EPA and NIST enabled the first FDA approval for testing a 500 G 60 Hz electromagnetic device for the treatment of muscle pain..
His work with FDA and NIST enabled the first FDA approval of a clinical ophthalmic tandem scanning ophthalmoscope.
CLINICAL
MCL handles all aspects of clinical investigations. In addition to assisting in the early stages of development and submission we can locate investigators, prepare report forms, and attend to necessary interactions with FDA and IRBs. MCL has created, and when necessary, updated report forms for contact lens studies, artificial tear studies, punctum plugs and silicone oils for intra-ocular use. MCL has monitored and even served as sponsors for clinical studies, then compiled and submitted the documents to FDA
Investigational sites
Investigational sites are selected to obtain credible P.I.s who can and will devote adequate time and effort to complete a study within reasonable time limits.
Report forms
Report forms are prepared in cooperation with each sponsor to enhance assurance that protocol-directed responses are answered. In addition, inclusion-exclusion criteria are highlighted where appropriate. Even in the best labs, not everyone involved in a study memorizes the protocol. We recognize the importance of the user interface by creating user-friendly forms, many of which are unique to the project at hand. These forms are complete and fulfill all protocol reqluirements, but requiresw a minimu of handwritten entries..
Post Submission
MCL will meet with FDA prior to, during and following submission of documents; we will interface between your facillity and FDA regarding problems including warning letters and responses to 483s..
