The next frontier of global industry expansion makes its home in Brazil, Russia, India and China (BRIC). Imagine the impact of a patient pool that numbers 3 billion: an immediate cure for patient shortages (or recruitment challenges) that plague studies in North America and Western Europe, unparalleled access to untapped patient populations, and new opportunities to meet the growing medical needs of these countries.

Despite vast promise as the next major growth opportunity for life sciences companies, the BRIC countries collectively represent a daunting challenge to new product development strategists and clinical operations teams. Any number of unknowns — unfamiliar regulatory guidelines, intellectual property concerns, time and distance barriers, and tolerance of dishonest business practices — can cause companies to hesitate to invest in these emerging markets or keep them out altogether.

Confidently tap into the potential of the BRIC markets, fulfill protocol, and ultimately, realize significant cost and time savings. Expand your understanding of BRIC, individually and as a whole, using rankings data and best practices to map out a winning clinical strategy:

Eliminate Confusion about BRIC

Weigh the advantages and drawbacks of different countries and examine rankings for 13 clinical factors to enable strategic decision-making. Gain quick access to relevant demographics and economics information for a comprehensive analysis of the clinical environment.

Master Trial Management in Emerging Markets

Learn from top executives’ firsthand experiences — both successes and misfires. Recommendations show your team how to improve CRO selection, management and oversight, and more. Explore 23 in-depth profiles and find one that matches your company’s situation.

Clarify Misperceptions to Boost Success

Differences in cultural attitudes and behavior impact trial success. Knowledge and awareness go a long way in cultivating strong and beneficial relationships with local CROs.

* Average percentage of budget saved by running a site in BRIC markets
* Average percentage of time saved by running a site in BRIC markets
* Population comparisons between BRIC nations, the United States and Europe
* Number of registered studies across profiled BRIC countries
* Rankings from surveyed companies of benefits and challenges:
o Patient access
o Patient retention
o Regulatory environment
o Intellectual property laws/practices
o Cultural concerns
o Communication and language
o Clinical trial technology infrastructure
o Supply chain management
o Investigators’ available knowledge base
o Data standards
o Investigator standards
o Site management standards
o Anticipated cost

The four chapters in Emerging Markets Clinical Development Series: Brazil, Russia, India and China (BRIC) use primary and secondary information to provide comprehensive overviews of the clinical development environment in each of the BRIC countries. Each country overview contains these elements:

Section 1: Clinical Development Environment

* Key demographics (population/ethnic breakdowns, life expectancy statistics)
* Key economic figures (GDP, labor force, distribution of family income)
* Disease prevalence
* Politics
* Healthcare system
* Pharmaceutical market (overall picture of market, leading local companies)

Section 2: Clinical Development Strategy

* Percentage of budget saved by running a trial in this location
* Percentage of time saved by running a trial in this location
* Assigning clinical development responsibilities

Clinical Trial Environment Scores and Trial Operations Scores:
Environment

* Available knowledge base
* Regulatory environment
* Intellectual property laws and practices
* Communication/language
* Culture
* Anticipated cost

Operations

* Access to patients
* Patient retention rates
* Investigator standards
* Data standards
* Site management standards
* Trial technology infrastructure
* Supply chain management

Section 3: Individual Company Profiles

This report contains a total of 23 company profiles that contain the following components:
Company Background

* Company mindset and key clinical feasibility factors
* Factors that impact clinical environment

Clinical Environment Assessment

* Regulatory environment
* Available knowledge base
* Intellectual property laws/practice
* Communication/language
* Cultural concerns
* Anticipated cost

Trial Operations Assessment

* Access to patients
* Patient retention rate
* Investigator standards
* Site management standards
* Data standards
* Trial technology infrastructure
* Supply chain management

Experience in Region

Activity in Region: Maps the geographic scope of the company’s clinical operations within the region. Experience Specific to Country: Provides information on the company’s operations within the country, including year of entry, method of entry and current level of presence within the country.
Clinical Strategy in Country

Responsibility breakdown shows each company’s clinical operations assignments among four groups – corporate team outside country, corporate team inside country, multinational CRO, and local CRO/ vendor. The data detail 12 clinical responsibilities:

* Protocol development
* Site selection
* Investigator training
* Patient recruitment
* Site monitoring
* Investigator management
* Data collection
* Data management
* Data cleaning/analysis
* Medical writing
* Regulatory agency communication
* Health economics consideration

Clinical Environment and Trial Operations Scores

Shows a company’s score for each of the clinical environment and trial operations factors listed above.

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Successful teams win this race by minimizing risks, eliminating trial unknowns and hitting study deadlines. Supported by ample resources, they build process improvements through performance measurement and charge ahead with new techniques to accelerate trial timelines.

Designed to benefit teams and individuals in any role in the clinical trials space, this study will help teams achieve clinical operations efficiency — and realize the significant payoffs that accompany successful drug development:

*      Save time through adaptive trials:
Learn how leading-edge companies use adaptive design to accelerate trials and achieve the desired endpoints. Understand the FDA’s new guidance and get a real sense of where the industry stands on this new frontier.
*      Track the right metric at the right time:
Track 26 operational, timeline and resource metrics across the five development stages using realcompany data from 80-plus trials. Learn how to incorporate forecasting software into trial design and planning.

*      Benchmark and manage resources:
Break out individual costs and compare per-patient investments across five major therapeutic areas for Phases 1 through 4. Track staffing trends and coordinate in-house and outsourced teams.

* Factors most responsible for increased clinical trial costs
* Average per-patient clinical trial costs across all therapeutic areas — 2008 and 2011
* Average percentage of clinical trial costs outsourced across all therapeutic areas — 2008 and 2011
* Per-patient clinical trial costs, broken down by phase, for these therapeutic areas:
o Cardiovascular
o Oncology
o Central Nervous System
* Average percentage of clinical trial costs outsourced across all therapeutic areas — 2008 and 2011
* Diabetes
* Hematology

Chapter 2: Clinical Trial Staffing Benchmarks
31 charts focus on clinical staffing data, and 5 tables provide staffing figures broken down by phase:

* Total trial staffing by phase
* Overall percentage of staffing outsourced by phase
* Average patients and average sites per CRA, by phase

These metrics are broken down by phase:

* Actual patients/sites per CRA
* Clinical trial staffing and average staffing by position
* Average percentage of FTEs outsourced by phase:
o CRAs/monitors
o Trial managers
o Clinical directors/VPs & TA program supervisors
o Data management
o Medical writing
o Biostatistics/bioanalytics
o Average percentage of regularory FTEs outsourced by phase
o Clinical Quality Assurance (QA)
o Clinical trial supplies
o Chemistry Manufacturing and Controls (CMC)
o Contract management
o Drug safety

Chapter 3: Clinical Trial Performance Metrics
19 charts focused on these clinical development topics:

* Average number of metrics collected by phase
* Prevalence of time, operations and resource metrics collected across all clinical trials and broken down by phase

Time

* Average time to close a database
* Average time to initiate an investigational site
* On-time protocol completion
* Time to completion of clinical trial
* Time from statistical tables complete to clinical trial report complete
* Time from database lock to statistical tables complete
* Time from first patient in (FPI) to last patient out (LPO)
* Time from last patient in (LPI) to last patient out (LPO)
* Time from last patient out (LPO) to database lock
* Time from last patient out (LPO) to statistical tables complete
* Time to randomize a target number of patients
* Time to enroll a target number of patients

Resource

* Overall cost per patient enrolled
* Overall cost per patient randomized
* Cost per clean Clinical Research Form (CRF) page
* Budget to completion of a trial
* Patients per CRA
* Sites per CRA

Operations

* Investigator recruitment rates
* Case report forms collected per CRA per day
* Patient enrollment rates (per site)
* Patient retention rates
* Patient randomization rates (per site)
* Site retention rates
* Advertising/marketing results
* Data error rates

Chapter 4: Adaptive Clinical Trials
13 charts focusing on adaptive design:

* Percentage of companies using adaptive design in clinical trials
* Rating adaptive clinical trials design effectiveness versus traditional clinical trials design
* Percentage of adaptive design usage in clinical trials by development stage
* Likelihood of adaptive design usage in clinical trials by development stage
* Impact of adaptive design usage in clinical trials on trial cost, aggregate and by company
* Impact of adaptive design usage in clinical trials on trial duration, aggregate and by company
* Importance of factors for using adaptive design in clinical trials
* Percentage of companies that unblind data during interim analyses in adaptive clinical trial designs
* Percentage of companies using third party or DMC during interim analyses in adaptive clinical trial designs
* Prevalence of usage of adaptive design types, aggregate and by company