Clinical Trials

MedSurgPI’s extensive experience in the planning and guidance of clinical trials enables us to assist you with the following:

1.    Creating, Planning and Directing Clinical Trials
         a.  Phase I-IV
         b.  Observational Trials
         c.  Investigator Initiated trials
         d. Comparative Studies

2.     Contract Research Organization selection and management

3.     Protocol creation

4.     Regulatory strategy

5.     Recruitment optimization

6.      Problem solving when the unexpected occurs in the course of clinical trials.

7.     Reviewing the combined statistical and clinical report

8.       Coordinating Investigator pre- and post- study meetings

CRO Recovery and Trial Clean Up

                        1.  Problems and solutions identified.

                        2. Study Protocol, Timelines, Expected Results, Adverse Events and organizational plan reviewed for                                         appropriateness and improvements to reach agreed upon goals.

                        3. New approach will be proposed in the most expedited time-sensitive economic manner.

Medical Foods

                         1. Regulatory Strategy

                         2. Commercial Planning
                                    a. Reimbursement
                                    b. Sales

                         3. Clinical and Medical Affairs        

Safety and Pharmacovigilance

  1. Experienced Medical Monitors

  2. Adverse Event Reporting

  3. Use of Large Validated Safety Database

  4. Strategic Product Positions with Post Marketing Vigilance Development

  5. Postmarketing Reporting

  6. Guidance for Investigators