medical writing services

Innovative Analytics, Inc. www.ianalytics.biz 269.488.3200

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:

2009—2010—2011

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

Innovative Analytics, Inc. www.ianalytics.biz 269.488.3200

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:

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.

@IAnalytics_CRR

linkedin.com/in/cynthiarutgers

For new business opportunities, please contact:

Cynthia R. Rutgers

Executive Director, Business Opportunities

Mobile: 714.474.1250 Email: [email protected]

2009—2010—2011

Analgesia Oncology

Cardiovascular Renal

CNS Diseases Urology

Endocrine Women’s Health

Infectious Diseases Inflammation