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).

Procedures

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.

Because
all projects are different, we encourage you to call to determine how
we can best serve you. Initial consultations or consultations to provide
options are free of charge. (If you just need help with writing or
rewriting a scientific paper, please visit our scientific material page.)

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!

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 2: Original research in medicine
In
another case, a medical practitioner whose research experience was still
relatively limited needed some help in writing his data for various
papers. First, we became familiar with the literature that would need to
be cited. (We also conducted a search for more recent and relevant
literature.) Second, we drew up outlines for two papers, which would
detail different aspects of the work, wrote the first drafts of both
papers after approval of the outlines, helped him select appropriate
journals for submission, and reviewed all the criteria for original
research contributions.

Next, we created a series of figures
based upon both Excel data and datasets created from SAS and SPSS.
Finally, the papers were written in AMA style, reviewed by all the
authors in detail, and all the proposed changes incorporated. In
addition, we provided complete details for clinical trial registration,
since we had determined that the medical intervention carried out needed
to be registered before the papers could be submitted.

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!