1. Medical Writing
The success of a clinical development program depends on the science that goes into it. Equally important, however, is
the ability to take the results of the research and convey them in a cohesive and unambiguous manner so that the
concepts are clearly understood and in a format that is acceptable to the end customer: other clinicians, scientists, and
regulatory reviewers.
Within the pharmaceutical, biotechnology, and medical device industries, there is a demand for competent, knowledge-
able, and self-directed individuals who can understand the complexities of clinical research and translate the data into the
words that will get the product to market as soon as possible. It’s not always possible to have the medical writing ex-
perience that is needed on staff when it’s needed. That’s where we come in.
Key messages are clearly and consistently conveyed
Our medical writers are an expert source of knowledge on the scientific, regulatory, and industry requirements of all of
the types of documents that span clinical development, registration, and beyond. We will ensure that your key messages
are conveyed accurately, consistently, and clearly across all of the documents in your clinical development and registra-
tion programs for drugs or devices.
Highest professional standards
Innovative Analytics’ medical writers are certified by the American Medical Writers Association (AMWA). Their train-
ing means they know the content, format and structure guidelines required by the regulatory agencies and peer-reviewed
journals.
Their real-world experience gives them the skills needed to manage all aspects of the writing process, including author
relationships, timelines, and crises associated with changing timelines and priorities.
Full service medical writing
Innovative Analytics’ full-service medical writing services include:
Protocols Safety Update Reports
ICH Compliant Clinical Study Reports Briefing Documents for Regulatory Meetings
Patient Narrative Summaries Responses to Regulatory Agencies
Investigator’s Brochures Advisory Committee Brochures
Investigational New Drug (IND) Applications Manuscripts
Integrated Summaries of Efficacy US, European, and Canadian Regulatory Submissions in
Common Technical Document (CTD) Format
Integrated Summaries of Safety
2009—2010—2011
Innovative Analytics, Inc. www.ianalytics.biz 269.488.3200
2. Attentive, responsive service and support
We demonstrate an intense attention to detail with regard to scientific content, regulatory guidelines, specialized medical
vocabulary, and consistency in terminology, key concepts, and grammar and syntax. We understand that attention to
detail is a key component to the success of any document, and we remain steadfast in our quest to produce documents
that meet the highest professional standards for quality.
Expertise in challenging research
Therapeutic expertise and knowledge of global clinical development can help you reach your clinical development goals.
Innovative Analytics’ therapeutic experience includes:
Analgesia Oncology
Cardiovascular Renal
CNS Diseases Urology
Endocrine Women’s Health
Infectious Diseases Inflammation
Value proposition: Save time, control costs
The expert medical writers at IA focus on adding value through their contributions to clinical research.
Their expertise in the scientific, regulatory, and industry requirements of all types of clinical documents is reinforced by
their ability to understand and convey “key” messages in a cohesive and unambiguous manner within and across
documents.
Global reach
As clinical research extends its global presence, so does Innovative Analytics. We
provide services in the Americas, Western, Central, and Eastern Europe, and the
Asia/Pacific region. Recent projects involved Russia, the Czech Republic,
Georgia, Moldova, Armenia, Iceland, Cyprus and Israel.
For new business opportunities, please contact: @IAnalytics_CRR
Cynthia R. Rutgers
Executive Director, Business Opportunities linkedin.com/in/cynthiarutgers
Mobile: 714.474.1250 Email: cindy.rutgers@ianalytics.biz
2009—2010—2011
Innovative Analytics, Inc. www.ianalytics.biz 269.488.3200