Site Support

PI Meetings

If you are investing in a patient recruitment/retention campaign, Axiom encourages you to get site buy-in early. When possible, we suggest presenting the recruitment/retention campaign details at the Investigator Meeting.

It is at this meeting that a face-to-face rapport can be established with the PIs, Study Coordinators and recruitment staff. Details of the campaign can be presented, collateral materials and ads can be displayed and questions can be answered, all while increasing study team motivation and enthusiasm.

Site Consulting

As we all know, sometimes enthusiasm or site ability creates a lag in subject enrollment. Whatever the reason, an enrollment lag affects motivation levels, budget and FDA submission timelines.

Axiom will recommend solutions to regenerate enrollment activity. This effort may include site enhancement through surveying, site coaching, time management training, patient recruitment effort re-direction and media placement assistance, to name a few.

Site Communication

As a strategic partner, Axiom recognizes that sites have many points of contact. Our goal is to keep communication consistent
and simple.

Axiom assigns one to two main contacts to ensure site comfort and to eliminate confusion. We provide regular follow-up to ensure that site’s patient recruitment needs are met. Site conference calls are often necessary to re-motivate site staff, answer commonly occurring questions, share subject recruitment/retention ideas and discuss changes or challenges in the protocol.

Axiom will organize, set-up and manage regularly scheduled site conference calls. These calls can be geographic or media market specific. We also have the ability to organize and implement other advanced communication forums.

Collateral materials

Collateral materials are the fundamental elements of any patient recruitment effort. Brochures, posters, and physician referral pads are just a few. It is particularly important to provide educational collateral materials when trying to reach those difficult-to-reach patient populations. No matter which collateral pieces you choose, each can be branded so the study is instantly recognizable.

Axiom’s in-house copywriters and graphic design department work together with the project managers to ensure a focused message and powerful design grab the attention of the reader. We can also design a study logo and implement its use across all messaging outlets. Descriptions of our Patient Directed and Physician Directed collateral materials follow:

Patient Directed Materials

Materials are developed to attract the attention of potential study subjects or their family members. Patient directed materials may include posters, flyers, brochures, letters, etc.

Professional Directed Materials

Materials are developed to attract the attention of potential referring professionals. These referring sources may include physicians, medical educators, support group leaders, etc. Professional directed materials may include letters, brochures, postcards, referral pads, etc.

Mailings

Direct mailings, either via postal service or e-mail, can be implemented as a stand alone or can be used as a solid supplement to other patient recruitment initiatives. Descriptions of our Direct-To-Subject Mailings and Referral Mailings follow:

Direct-To-Subject Mailings

Mailing directly to ailment specific populations that live or work within a close proximity to the site will generate local study inquiries. It is also a significant way to begin the branding awareness process. All compiled mailings are monitored with opt-in, HIPAA-compliant quality controls.

Referral Mailings

Axiom helps sites locate and reach out to other physicians, medical educators, support group leaders and other medical professionals by coordinating referral mailings. These mailings promote the study within the medical community and generate subject referrals.

 

 

Community Outreach

The purpose of a community outreach initiative is to create awareness of the research study, inspire local support and generate word-of-mouth study referrals.

The message can originate on school campuses or in community centers, specialized health organizations, churches, town halls, grocery stores, etc.

The goal is to have educational study information available at any location where potential patients, caregivers, or medical professionals may look for support and/or information.

On behalf of the study sites, Axiom contacts relevant organizations and facilities to stimulate study support. On more than one occasion, there have been entire events planned around building research study awareness. These events get community members involved, educated and motivated.

Axiom will develop and implement all elements of the outreach initiative so Study Coordinators have the time to focus on patient care.

The desired community outreach outcome is to positively impact the overall patient recruitment and retention effort.

 

Public Relations/Media Awareness

A Public Relations (PR) campaign’s purpose is to generate and maintain positive publicity about a particular research study. Axiom recommends a PR campaign when the study is newsworthy, timely and has mass appeal.

PR can shape the public’s image of a research study and generate local, regional and/or national recognition, which in effect can boost subject enrollment quickly.

Publicity is achieved by communicating with the public via the media through a variety of avenues: press releases, letters, press conferences, interviews, speeches, special events, webinars, articles, newsletters, etc.

The desired PR outcome is to positively impact the overall patient recruitment and retention effort through print, word-of-mouth and electronic mediums.

 

 

 

Response Capture

Study Web Site / Interactive Voice Response System (IVRS)

Axiom develops custom web sites and IVR systems that allow respondents to be pre-screened for basic inclusion/exclusion criteria. The web sites and IVR systems are used as a response capture medium for potential patients, caregivers, etc.

These systems can include pre-screening questions and immediate site phone, fax and e-mail transfer abilities, as well as several other metric-capturing capabilities. All data collected from respondents from both the web and IVRS is reported in real-time reports on the Study Team web site. Click here for more information about the Study Team web site.

The web site is also utilized to provide educational information to potential participants, caregivers or other members of the treatment network. Information about clinical trials, the research study and relevant resource web site links can all be included.

Site Specific

If a centralized IVRS is not in use, customized programs can be developed to assist the sites in capturing the source of the response.

Social Networking & Mobile (Text) Messaging

Social Networking

• YouTube Media Posting
• Facebook Advertising
  • Geo-Targeting
  • Demographic Targeting
  • Online Communities
• MySpace, Twitter, etc.

Mobile (Text) Messaging

• Custom design/function for each study
• In-house mobile messaging specialists
• Can be used for recruitment, response capture, study awareness, appointment reminders, treatment instruction, etc.
• Global, multilingual capabilities

Metrics and Study Resources

Metrics Capture

Axiom is able to collect and track detailed metrics from web site visitors including demographic data, geographic location, etc. in order to meet the requests of the sponsor and effectively report up-to-date information on the Study Team web site and in customized reports.

Our IT department has the ability to accommodate just about any request for customized report layouts. The site is password protected for sponsor and site entry. Access to the web site is available 24/7/365.

Study Team Web Site

The Study Team web site is developed as a resource for everyone involved in the research study from the site to the sponsor level. It is here that study documentation can be shared.

Information commonly posted includes study timelines, downloadable advertising tools, contact lists, subject recruitment tips, subject retention tips, study updates, etc.

When a traceable message medium is used, such as a 1-800 telephone number or a web site, the Study Team web site will contain sponsor requested metrics with real-time updated status reports.

Think of this as a one-stop location for all study information and updates. The possibilities are endless!

Media Advertising

When media purchases become an element of the overall patient recruitment campaign or are used alone, it is important to evaluate the history and capabilities of the sites, but also their location.

In an ideal situation, Axiom recommends providing a market analysis before site selection is final. This will provide insight into the site’s regional demographics and make the best use of your advertising dollars.

We have seasoned copywriters that work with our graphic design department to create effective and inspiring advertisements. We can provide the copy, graphics and production services for the following:

• Print ads
• Radio spots
• TV commercials
• Internet ads

Media plans are carefully reviewed before any purchases are made to ensure site preferences are accounted for and that commercial placement reaches the targeted audience, runs frequently enough to build credibility and generates the desired response.

All elements of the media campaign development are effectively implemented by one source.

We offer one of the most flexible cancellation policies in the industry which allows us to adjust to response rates and site capabilities within 48 hours.

Patient/Subject Retention

Patient retention campaigns, also referred to as subject retention campaigns, are designed to keep patients enrolled in the study.

Many factors can be attributed to study withdraws, but patient retention tactics can be implemented to limit this possibility (i.e. Study Coordinator training during the Informed Consent process and patient motivation tools).

A subject retention strategy should be developed when a protocol includes any of the following criteria: study visits are scheduled far apart, study participation is longer than six months, invasive procedures are required and constant motivation to stay study-compliant is required.