Case Studies

Publication Strategy

Situation: Leading MDx company wants to publish clinical findings by users.  Need to develop and execute strategy to gain exposure at national meetings, then follow with publications.

Solution: engage with physician users, assist in data analysis, craft story in collaboration with company and users.  Write and submit abstracts, create corresponding posters, craft subsequent manuscripts, and submit for publication.  Follow until published.

Clinical literature review

Situation: Client needed complete review of published literature on a disease condition addressed by their device.  The search needed to cover the world literature for a five year period to support regulatory filings.

Solution: The available scientific and medical literature was subjected to a custom comprehensive search to identify all clinical research published in the target time frame.  Databases, internet, and other resources were searched.

Periodic literature search

Situation: biotech client wants to stay up to date on research developments related to their product area and market.  The client desired a periodic compilation of relevant scientific literature citations.

Solution: set up system for performing quarterly searches of the scientific and medical literature.  Literature searches performed and reports sent quarterly to client.

Clinical research meta-analysis

Situation: the client’s goal was to file for CE Mark on a device approved in the US.  Client needed a meta-analysis of clinical research in the therapeutic area to support the CE Mark application.

Solution: A meta-analysis of the clinical research on predicate device efficacy and safety was completed and delivered to the client as evidence of clinical safety and efficacy of the product.  Client used the analysis in their application and subsequently received the CE Mark.

Key Literature Repository

Situation: personnel buy and store key research articles on their own computers.  This leads to a large number of redundant purchases of published literature.  Client company wants to consolidate purchased articles into a searchable repository of key literature available to all employees.

Solution: Implemented a system for transfer of purchased research articles to a central file location.  Articles were deposited in a central repository on the company intranet and cataloged in a database system to aid location of specific articles.

Web site content development

Situation: client company was a development stage biotech needing an online presence.  The assignment was to develop web site content to tell the company’s story.

Solution: Interacted with company management, web developer, and video producer to write and publish content about the company, its history, its progress, and its goals in a format suitable to reference to investors.  The web site was up and running at the end of the engagement.

Government grant application

Situation: a funding program was put into place by the US government to cover development costs for certain innovative biotechnology projects.  The client firm goal was to apply for and receive these funds to cover development expenses.

Solution: Interacted with management to collect the required information on the company, development plans, and progress to date.  Created the application for funding and submitted it on behalf of the client.  Funding was awarded and received by the client.