consultation!

Below are three examples to illustrate some of the work we do.


Case study 1: CMS approval of device (NCD)

Our
client needed help because they had been twice rejected for national
coverage by CMS. We undertook the following over several years:

  • Reviewed the existing literature and conducted then published a systematic review and meta-analysis
  • Designed several RCTs and cohort studies to address deficiencies in the existing trials that had already been conducted
  • Wrote the protocols and helped them get approved by IRBs
  • Set up trial monitoring plans and statistical analysis plans (SAPs) from an analytic point of view
  • Got approval from CMS to conduct the trials under the CED program

 

Case study 3: Assessing use of silver-impregnated dressings in wound care
This was a multi-client request that was based on the need for an NCD. We:

  • Conducted a systematic review and meta-analysis of the literature and published it
  • Presented the results to CAC at CMS as well as several MAC directors
  • Worked with a registry organization to analyze wounds on usage using
    big databases derived from wound-specific EHRs and published the
    results.

For statistical analysis we use SPSS versions 19 and 21. We have
the capability to do simple statistical tests, such as one-way ANOVA, t
tests, and chi square or Fischer exact tests, regression, including
multinomial, logistic, or multivariate regression, univariate and
multivariate risk analysis, as well as GLM modeling. Costs for
statistical analysis vary but start at $500, which includes set-up using
Excel spreadsheets.

We perform some initial work in Excel,
including variable organization, cleaning up, and some computations,
prior to statistical analysis.

For many of our busy clients,
writing up the paper is not the only the work we do. In many cases we
also prepare a cover letter (which we always run by our clients for
approval), fill out all the forms after consultation, collect
signatures, and perform the actual submission. When the reviewer
comments are received, often we are asked to help prepare the Response
to Reviewers document, and make the necessary changes to the manuscript.

We know that it�s hard to be great writer, graphic designer, statistical expert, or literature search wizard when you�re busy practicing medicine or carrying out experiments in a lab. That�s why we�re here. Think of us as an extension of your practice or laboratory–a source of expertise or knowledge that can be of help when you want to carry out a study, write up a study, or help it get published when it seems reviewers and editors disagree don�t like your work. Give us a call or send us an email. There�s no charge for a consultation!

Case Study

sTRAYEGIC SOLUTIONS iNC. Case Study

Case study 1:

CMS approval of device (NCD)

Our client needed help because they had been twice rejected for national
coverage by CMS. We undertook the following over several years:

Marissa Carter

Marissa Carter

President, Strategic Solutions Inc

Current skills: clinical trial design; clinical study analysis; biostatistical analysis; systematic reviews; meta-analysis; EBM; health economics, including modeling; literature review; study and manuscript writing/critiquing.

Reviewed the existing literature and conducted then published a systematic review and meta-analysis

Reviewed the existing literature and conducted then published a systematic review and meta-analysis

Designed several RCTs and cohort studies to address deficiencies in the existing trials that had already been conducted

Designed several RCTs and cohort studies to address deficiencies in the existing trials that had already been conducted

 

Wrote the protocols and helped them get approved by IRBs

Wrote the protocols and helped them get approved by IRBs

Set up trial monitoring plans and statistical analysis plans (SAPs) from an analytic point of view

Set up trial monitoring plans and statistical analysis plans (SAPs) from an analytic point of view

Got approval from CMS to conduct the trials under the CED program

Got approval from CMS to conduct the trials under the CED program

Details

Taking Elegant Themes to The Next Level

Challenge

If you’re short of manpower or crunched for time in trying to complete studies or experiments or even
need a second opinion on some aspect of research, we can help you. And if it’s a subject outside the range of our expertise, we’ll let you
know. With the majority of projects, we can quickly provide a total cost, timeline, and list of what we’ll do, how we’ll do it, and when.

Solution

Because all projects are different, we encourage you to call to determine how
we can best serve you. Initial consultations to providing options are free of charge.

 

Annual Savings

500k

Return Users

12M

Sales Increase

20%

Traffic Boost

18%

free consultation

“As an extension of your practice or laboratory-a source of expertise or knowledge at your fingertips.”

John Doe, Divi CEO

Get In Touch

In general, we can provide you with the following capabilities:

  • Consulting
  • Clinical trial design�(design selection, sample size calculations, statistical analysis plans, protocol writing, detailed trial planning)
  • Statistical analyses–(from simple
    parametric/non-parametric testing to regression and modeling; datamining
    and relational database work; we offer both classical �frequentist� and
    Bayesian approaches)
  • Health economics research�(from simple cost effectiveness calculations to Markov models and discrete event modeling)
  • Systematic reviews�(literature searching, data extraction
    and compilation, evidence assessment, writing, clinical practice
    guideline writing, and meta-analysis from simple to complex modeling)
  • Medical literature research— (database searches and source compilations, reference verification)
  • Reports–(critique, writing, and rewriting)
  • Assistance with medical manuscript preparation�(drafting and writing in journal requirement style (AMA), and addressing referee comments in revisions).

1234 sAn Francisco, CA 12345
+1 555 0394 848
info@diviconsulting.com