Ridge Rim Associates, LLC: Clinical Communications

	Ridge Rim Associates, LLC
	Regulatory Documents and Clinical Publications Healthcare Manufacturing and Quality Systems Solutions

Clinical Communications

Regulatory Documents, Including:

Clinical Protocols and Amendments
Investigator Brochures
Clinical Study Reports
Integrated Summaries of Safety and Efficacy
Safety Updates
Responses to Questions from Regulatory Authorities

Clinical Publications:

Manuscripts
Abstracts and Posters
Slide Decks
Literature Searches and Evaluation

Related Clinical Services:

Writing Support for Statistical Analysis Plans
Assessment of Case Report Forms and Individual Patient Profiles to Identify Data Collection Issues Prior to Database Lock
Evaluation of Draft Statistical Output to Identify Potential Programming Issues
Preliminary Analysis of Clinical Data Prior to Medical Review

Therapeutic Areas Include:

Oncology Bone Metabolism Hemostasis	Immunology Autologous Cell Therapy Microbiology
Chronic Immune/Inflammatory Diseases (eg, Cystic Fibrosis, Multiple Sclerosis, HIV/AIDS, Psoriasis, Rheumatoid Arthritis)

Roberta has delivered a number of clinical study reports and manuscripts for our phase 1-3 development programs. The documents are unfailingly accurate, well written, and on time. Her services rank in the very top tier.
- LM, Director, Medical Writing

Roberta's medical writing services were instrumental in supporting our company's submission goals by allowing our in-house experts to focus on review activities and strategic issues.
- JS, Director, Regulatory Affairs

Roberta was able to quickly digest and interpret a large safety dataset, producing a high-quality Summary of Clinical Safety on time. She integrated the comments and questions received from a large, diverse group of reviewers, resulting in a coherent, comprehensive document.
- TA, Director, Clinical Research

I'm on page 90 [of the 120-day Safety Update] and I just had to say it is a thing of beauty.
Textbook perfect in my mind.
- TN, Sr. Director, Clinical Research