Our members are thought leaders in PD. Your study would be led by a PSG Steering Committee comprised of a study PI and Co-PI, three or four investigators, and a chief biostatistician. We guide you through the clinical trial process from start to finish.
The largest and most experienced network of committed & credentialed PD Centers. We have over 400 Credentialed Investigators at 156 sites across North America and are growing.
We have a unique process for site selection amongst our premier credentialed PD centers. Sites are pre-qualified based on study requirements, and our selection process takes between 4-6 weeks to complete.
The PSG is known for their scientific rigor and the highest quality publications. Our track record shows that we have completed more than 50 Parkinson studies with over 8,000 patients enrolled on deadline, if not earlier.
In order to participate all sites must sign off on the uniform per subject fee (decided in partnership by the sponsor and our study budget committee) which eliminates the need to negotiate numerous budgets, saving the sponsor time and money.
Sponsors can select from some or all of our services offered – from protocol creation to FDA application (see full list of services below). We have two great options for coordination centers that we are affiliated with, or you can choose our “hybrid model” and we can credential the CRO of your choosing. We can also provide a list of credentialed CRO’s that we have worked with on previous studies. Through our organization you will also have access to additional services such as meeting planning, credentialing of sites/investigators, facilitation of communication with sites and assistance in the publication process.
Our advisory boards are comprised of 5-7 PSG members who are experienced clinical trialists as well as key opinion leaders. The PSG can provide recommendations for members, but approval of the final composition of the panel is the responsibility of the sponsor. These advisory boards can take place in-person or virtually with the PSG administrative team taking care of all scheduling and meeting arrangements. Any meeting prep materials are due to the PSG two weeks prior to the meeting so that they can be distributed and reviewed before the group discussion. The focus of the advisory board is determined by the sponsor, but can address topics including, but not limited to, those listed below:
In addition to clinical protocol review as a component of PSG Advisory Board services, an independent, focused review can be provided from PSG Coordinator and Investigator perspectives:
Coordinator Protocol Review
A coordinator protocol review typically consists of between 3-5 seasoned PSG coordinators who are experienced in PD trials and actively participating in research at their institutions. We recommend a list of coordinators who are at geographically diverse institutions that vary in size and research support services. Coordinator reviews are specifically designed to answer practical questions regarding study protocol feasibility, execution, and patient participation, for example:
PSG Scientific Review Committee Protocol Review
The PSG Scientific Review Committee (SRC) is comprised of ten members with varying backgrounds in areas such as statistics, clinical research, basic science, genetics, and neuropsychiatry. The Chair and Co-Chair will assign a primary, secondary, and statistical reviewer for each proposed project. Their overall impact score is reflective of their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field involved and ultimately patient care and quality of life, in consideration of the following review criteria: significance, investigator(s), innovation, approach, and environment.
Additional criteria include a review of the budget and whether it is appropriate and well justified. The committee will then meet, allowing the reviewers an opportunity to present their scores, and the Chair & Co-Chair will moderate a discussion amongst the full committee. The formal reviews along with the meeting minutes will be provided to the sponsor upon their completion. If the study is being proposed as a PSG trial, the SRC will provide its evaluation and recommendations to the PSG Executive Committee for a decision on approval as a PSG study.
The PSG has completed more than 50 Parkinson’s studies, with greater than 8,000 patients enrolled, all on deadline. Our reputation is based on our scientific rigor and authoring the highest quality publications. There are five prerequisites for working with the PSG: all PSG studies must include a PSG Steering Committee, all sites must agree to comply with a uniform per subject fee, approval from our Executive Committee and our Scientific Review Committee, the ability for a PSG statistician to securely access the statistical analysis plan and complete dataset for an independent review, and authorship of the final publication.
Advantages of partnering with the PSG include: