Why invivodata
Why invivodata > Customer Testimonials
Why invivodata? Reliable PRO Data that Meets Trial Sponsor’s Data Collection Needs
invivodata is committed to delivering the most valid and reliable PRO data to meet trial sponsor needs and to maintaining the highest levels of customer satisfaction throughout every step of the process. There’s no better way to demonstrate this than through the words of some of our worldwide customers:
“We are very pleased with invivodata’s contributions to this program and their ability to accurately capture the critical data we needed to support FDA supplemental approval of AMITIZA®…Their staff was very knowledgeable about the scientific and practical aspects of PRO data collection, and their processes were found to be regulatory compliant during an FDA audit of their systems and practices, which was an important component of this approval.”
- Dr. Gayle Dolecek, senior vice president of Research & Development, Sucampo Pharmaceuticals, Inc.
"Every electronic diary vendor can meet the hardware requirements for ePRO, but invivodata does so much more. My first-hand experiences with the invivodata team have shown me how their proactive services really make a difference in keeping studies on track and running smoothly." - Lynne Rowe, Director, Clinical Operations, AcelRx Pharmaceuticals, Inc.
"We evaluated several other ePRO solutions and ultimately based our decision on the successful experiences we have had working with invivodata on three previous projects…We know that we can trust invivodata to design an eDiary system that will help patients capture real-time information about their pain — which will result in the most reliable PRO data possible.”- Dr. Uwe Schneider, Global Head of Sourcing Management , Grunenthal
“In studying PATANASE for the relief of allergy symptoms, we needed an efficient and specific data collection method that was easy for patients and investigative site personnel to use…invivodata met our tight enrollment timelines and delivered the scientific expertise and technology that were important to the success of this program.”- G. Michael Wall, Ph.D., senior director, Pharmaceutical Product Development, Alcon, Inc.
“We chose to work with invivodata based on its expertise in optimizing patient compliance and its experience in executing international trials. invivodata's methodologies are already delivering higher rates of patient compliance than we have seen with other electronic diary systems."- Dr. Gwendolyn Neibler, senior director of clinical research, Cephalon, Inc.
“We are very pleased with the results of this landmark trial and the manner in which invivodata captured this critical data,.Their understanding of the complexities of international clinical trials and their flexibility in meeting our changing trial needs, including the addition of significantly more sites and patients during the recruitment phase, was critical to its success.”- Dr. Jutta Amersdorffer, head of Clinical Operations & Pharmacovigilance, Allergy Therapeutics, plc
“We chose to continue working with invivodata based on the results they delivered during our first project…We trust invivodata to design an ePRO solution that patients – especially older patients - can easily use to record their assessments of pain, as it occurs. That type of real-time data is invaluable to the success of this program.”- Dr. Fred Dechow, president and CEO, Mediquest, Inc.
“invivodata’s expertise in designing and administering electronic diaries served an integral role in our ability to capture highly valuable and reliable data from our Phase II clinical trial of Gabapentin for individuals with DPN…We look forward to continuing to work with invivodata in our effort to reduce the development risk associated with bringing new therapeutic treatment options to market.”- Carl Pelzel, executive vice president and chief operating officer, Depomed, Inc.
“invivodata and Medidata developed a solution that our investigative sites will use to efficiently monitor all patient-collected data throughout the trial.”- Henrik Rasmussen, M.D., Ph.D., senior vice president of clinical, medical and regulatory affairs, Nabi Biopharmaceuticals
“After conducting a thorough competitive review, we selected invivodata® because it is best suited to meet our overall program objectives.”- Franz Hefti, executive vice president of development, Rinat Neuroscience
“We chose to work with invivodata based on its knowledge and experience conducting pain trials and its proven ability to deliver timely, accurate PRO data to sponsors…Having worked with nearly 5,000 migraine sufferers to date, invivodata truly understands the needs of our patient population. We are confident that it will help these patients provide the critical PRO data we need.” - AnnaMarie Daniels, vice president of clinical research, Advanced Bionics, LLC
“Our successful experience with invivodata’s electronic diary supports the case for adopting this technology as the gold standard for future clinical trials in analgesic drug development.”- Dr. Michael Gendreau, Chief Medical Officer, Cypress Bioscience, Inc.
“As primary endpoint data for this drug, it was critical that submitted data were collected using a proven methodology that would meet FDA 21 CFR part 11 requirements. “This approval validates our confidence in the self-report data collected with the invivodata eDiary system.”- Elizabeth Bancroft, senior director of regulatory affairs, Allergan, Inc.