EARLY PHASE STUDIES
With the increasing pressure biopharmaceutical companies have to discover and develop new blockbuster drugs, Phase I clinical studies are arguably the most critical stage in a trial. These studies not only have to determine whether a drug merits further clinical testing, but need to be conducted in a quick and efficient manner to expedite crucial “go/no-go” decisions. As an organization, our skills are poised towards early phase data management services. We provide rapid turnaround timelines unparalleled in the industry, and offer a more personalized approach to streamline this crucial stage for you.
We understand that sometimes things don't go as initially planned. Our years in the industry have allowed us to develop valuable skills to quickly salvage and rescue studies. Our personalized approach during the early phase studies allows us to identify key issues regarding your study and formulate a corrective action plan to put things back on track. Rest assured that with us, you are in good hands.
Solution > CDM Expertise
LATE PHASE STUDIES
Typical Phase II & III studies often involve costly and time-consuming challenges such as multiple centers, procuring vendors, and increasing trial complexity as preliminary results are determined. They can also reveal irreversible long term damage or procedural flaws if start-up activities were not handled appropriately. We specialize in handling challenging late phase studies, and come prepared with strategic start-up activities and a definitive execution plan to make your trial run smoothly from start to finish.
We're quite versatile with our experience in terms of various therapeutic areas, as follows: Oncology, Rheumatology, Immunology, CNS, Cardiovascular, Endocrinology, Gastroenterology, Infectious disease, Psychiatry, Respiratory, Infectious disease, Pain, Women's health, Medical device studies.
Unlike study CRFs, data acquisition for PRO/ePRO requires the use of procedures that make it easy for patients to enter their data at their own pace and preference. We incorporate methods to not only facilitate data acquisition for paper or electronic PRO via online or offline services, but also to address other challenges unique to ePRO set-ups. We know that the key to efficient ePRO data acquisition is to proactively envision any challenges, and to prepare effective solutions for the patients participating in the trial.
Integrated supports working through an FSP model to utilize a sponsor's processes and systems for a particular task or the entirety of data management functions. We consider ourselves capable at being subject matter experts for specific data management activities. We strive to achieve higher rates of predictability and offer consistent delivery of services across all protocols.
The need for standardizing your submissions cannot be undermined. At Integrated, we adopt CDISC data standards to streamline clinical data submission to improve data quality and customer satisfaction so you get a competitive advantage.