The Integrium Researcher                      
October 2013


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Randa Rahid
Randa Wahid
Associate Director, Business Development
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Mike Loftus
Mike Loftus
Executive Director, Business Development

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Integrium
Clinician ECG with human
Rapid Patient Recruitment 
Thorough Execution of 
Phase I-III Clinical Development Programs
 
The New Dynamics of Clinical Research
 
 
The contract research organization (CRO) industry has grown in response to demand by biopharmaceutical and medical device companies for Phase I-IV clinical services.
 
Mark Powers
Mark Powers
Chief Enrollment Officer

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The demand reflected sponsor capacity shortfalls.

When a sponsor lacked sufficient internal resources for a study or program they would look outside the company for a qualified service provider.

Early Stages

As the global clinical research industry evolved, CROs were tasked with supporting a broad range of Phase I-IV clinical trial activities.

In response, many adopted a full-service model that allowed them to support the entire study process.

Click here to read more about the history of the CRO industry.

Click here to read more about Integrium's full-service clinical support.

Fueling Growth

The dynamics of the global clinical research market continue to evolve. For example, some small and mid-size biotech companies now plan to conduct Phase I-II research using in-house expertise.

Funding for research is often provided by outside investors who have access to capital but lack the insights they need to find common goals that bridge their interests with the interests of biotechs.

Linkage is important because capital providers and biotechs - both of whom are venture-backed - are under financial pressure.

Nearly Full Circle

This new (and urgent) demand to link outside capital with researchers represents a genuine paradigm shift. To fulfill their commitment to being full-service, CROs are challenged to expand their definitions of who they are and what their clients need.

Integrium is a great example of how a company can successfully adapt to change.

We looked carefully at how small biotechs are navigating today's research environment. We found, for example, that many are staffed with ex-CRO veterans with highly specialized skills and networks.

With sufficient internal resources, some biotechs now prefer to provide their own services. To bridge the gaps, we offer stand alone services.

Click  here to contact Integrium.
 
Managing Phase I-IV Clinical Study Risk 
 

  

Identify and Avoid Obstacles

Our research has identified three common points of failure before study completion:
  1. Serious Adverse Events (SAE's)
  2. Early indication of compound failure
  3. Finding patients
Assuming you have a solid compound and pass SAE's, patient enrollment is the single most common barrier between you and clinical study success.

With this aspect of a clinical trial often being a challenge, sponsors have also included more stringent inclusion and exclusion criteria.

Respond to Industry Needs

Integrium has redesigned the company to focus on patient recruitment and retention by requesting sponsors work with us months before study start date to analyze the types of patients we need in the study and allow for quicker enrollment. 
 
Click here to talk with Randa about patient recruitment strategies.
 
Click here to learn more about Integrium. 
 
Why We Attended the Annual BIO Investor Forum
 
 

The diversity of responsibilities borne by the global clinical research industry can be gauged, in part, by the number of local, national and international conferences held throughout the year.

 

Conferences Reflect Industry Evolution

 

Integrium staff regularly attend major conferences, such as DIA, but the one meeting we've grown to appreciate is the Annual BIO Investor Forum.

 

Although it is viewed by some as relevant primarily to investment activities, we've found that decision-makers at sponsors and investors sometimes need specific information about clinical research in order to make informed funding decisions.

 

Bridge the Gaps

 

Data provided by BIO Investor organizers verifies our assessment of the various interests at the conference: 

  • Nearly 80% of all meeting requests were between biotech companies and investors. 
  • Nearly 110 late-stage private and emerging public company gave presentations. 
  • 44% of all U.S. therapeutic IPO companies since 2011 attended BIO Investor Forum as a private company.
These numbers clearly show that there is a strong need to connect outside capital with clinical research expertise.
 
Help Your Organization Bridge the Gap
 
If you want to talk about bridging the gaps between organizations, please feel free to email me.
 
Click here to learn more about Integrium.