Our experts bring extensive therapeutic knowledge and insight into assisting life science firms in developing and executing their regulatory strategies, clinical development, and post-approval research. View our library of best practice eBooks, webcasts, and infographics, that will guide you along the path to successful drug and medical device development programs. Click on an operational or therapeutic area below to download free best practice resources.
- Nephrology and Urology
- Clinical Manufacturing
- Drug Development
- Infectious Disease
- Medical Device
- Patient Recruitment
- Risk Based Monitoring
- Study Startup
Eliminate barriers and increase participation rates
Oncology trials are sensitive in nature and require specific clinical expertise to properly manage. At Clinipace, we have the experience and expertise to guide you successfully through a wide range of multi-phase global oncology clinical trials. Although many barriers or reasons for failure can’t be predicted, with Clinipace Worldwide, you can lay the groundwork — including a solid study design, an experienced team, and the right technology — that will position your development program for the most likely chance of success.
A key factor in progress toward better treatment and prognosis in oncology lies in improving participation rates. We will help you improve those rates through the use of an adaptive and simplified trial design, molecular profiling, patient-centric enrollment, and communication and education.
- Nephrology & UrologyNephrology & Urology
Nephrology and urology experience by your side
We have experience with a wide range of multi-phase global nephrology and urology studies, including immuno-suppression, chronic kidney failure, renal cell carcinoma, contraception, female infertility, lupus, and more. At Clinipace, we have the expertise to successfully guide you through IND and CTA submissions.
We realize nephrology and urology clinical trials face high costs, issues with patient recruitment, and have a need for international sites. Working with Clinipace’s clinical experts and unified technology platform, TEMPO™, we can help to address these challenges for you. TEMPO allows for protocol, patient profile data, and data from all sites to be stored and accessed in a central database that is updated in real time, enabling visibility across the entire trial life-cycle, increasing data quality, and facilitating proactive, informed decisions.
We can also guide you through a risk-based approach to monitoring, which applies a systematic process to the trial life-cycle components (designing, conducting, evaluating, and reporting the trial) that help prevent or mitigate important and likely risks to data quality and participants. In this way, risk-based monitoring places a focus on quality metrics, including enrollment and data completeness, among others.
Clinipace offers experience in renal dialysis:
- Phosphate binders
- Erythropoesis stimulating agents
- Catheter lock solutions
- Iron supplements
- Vitamin D analogues
Helping you bring new therapies to patients with digestive diseases
Researchers and clinicians face a unique set of challenges during the development of pharmacologic agents for the treatment of GI disorders. One of these challenges is the stringent requirements imposed by regulatory bodies on all phases of drug development. Clinipace’s Regulatory & Strategic Development Global Consulting (RSD) experts can guide you through regulatory requirements, including approval by multiple institutional review boards, development of complex study designs, training investigators, and establishing contracts with other agencies and clinical centers to recruit eligible patients and implement the study protocol.
Gastroenterology is a rich research environment, but it’s also competitive, and changing at a rapid rate. Our team of therapeutic experts have extensive experience with global, pivotal gastroenterology Phase 1 – IV studies across multiple indications.
Some key areas of specialty include:
- Crohn’s Disease
- Ulcerative Colitis
- Gastro-esophageal Reflux Disease and
- Pediatric GI Expertise
Working with Clinipace Worldwide, you will have a solid study design, an experienced team, and the right technology — collectively which will position your development program for the most likely chance of success. A key factor in progress toward better treatment and prognosis in GI lies in improving participation rates. We have close working relationships with investigators and sites that ensure our ability to conduct a preliminary feasibility assessment quickly to predict enrollment and identify potential challenges.
Working with Clinipace and TEMPO™, our fully-integrated technology platform, during study management can also help with patient recruitment in your gastroenterology study. The ability to view and monitor the number of patients enrolled at every investigator site can help ensure the study is on track right from the start. If enrollment is below expectations, study teams can adjust their strategies and quickly make decisions on how to increase enrollment.
The use of TEMPO for functions like endpoint adjudication and remote site monitoring reduces cost, improves accuracy, and enables faster study close-out. Real-time data access also enables adaptive study designs that require fewer patients and increase likelihood of successful outcomes, and provides early identification of safety signals.
Control your nutrition trial costs through real-time, risk-based monitoring
Traditional, on-site monitoring visits can account for up to 30 percent of your study costs. With TEMPO, you have access to a technology-amplified, risk-based approach to monitoring that gives you the visibility and reduces the need for on-site monitoring visits. In addition we ensure integrity of trial data and patient safety, optimize trial efficiency and quality, and streamline sponsor, CRO, and trial site team interaction all while ensuring your study costs will be lower than the industry average.
We offer expertise with:
- Infant formulas
- Total parenteral nutrition (TPN)
- Functional foods
- Food hypersensitivity (e.g., peanut)
- Food for Special Medical Purposes (FSMP)
- Nutritional intervention for autism
Cardiometabolic diseases are no longer “Western” diseases confined to developed nations. The rapidly growing economies and Westernized lifestyles of emerging nations in Asia, Latin America and Eastern Europe are characterized by increasing incidence of chronic diseases. Cardiometabolic therapeutic innovation is clearly a global enterprise.
Clinipace Worldwide can help you conduct successful multinational studies by gaining operational proficiencies and ensuring consistencies across local regulatory requirements, treatment landscapes and varying standards of care. By making the best use of our unified technology platform, TEMPO™ eClinical, we enable integration and collaboration among functions across the spectrum of clinical trials operations country-by-country.
We’ve been there before
Given the complex nature of diabetes studies, robust statistical analyses are typically needed to account for potential confounders. Based on our expertise in experimental design, statistical analyses, and regulatory requirements appropriate for diabetes studies, we can help develop the most appropriate analysis plan to ensure success during your protocol development.
Identifying the most appropriate study population during the initial planning phase can be another challenge in diabetes studies. Having access to this population through our global network of experienced sites and investigators is a huge advantage that can save you valuable time and resources.
We have extensive experience managing multi-phase diabetic drug, biologic, and device trials, including Phase I-IV clinical trials, IND and CTA submissions, eCTD submissions, and statistical consulting.
- ENT, Eye, & RespiratoryENT, Eye, & Respiratory
We maximize the potential for the success of your drug candidate
Developing therapeutic agents for applications in otolaryngology; or ear, nose, and throat; ophthalmology; or pulmonary/respiratory necessitates the expertise of the right CRO.
By partnering with Clinipace Worldwide, we can help manage your entire ENT, ophthalmology, or respiratory drug development program, or conduct an individual trial. Our experts bring extensive therapeutic experience in building a well-defined strategy and clinical plan to maximize the probable success of your drug candidate. Our clinical teams can help operationalize your study protocol and provide unprecedented visibility into your studies through our unified technology platform, TEMPO™ eClinical.
Additionally, with TEMPO, you have real-time access to global study budget data and the ability to remotely monitor patients without need for costly site visits. In the end, we work to provide you with a more efficient and affordable program that minimizes data integration, reduces project startup costs, and empowers stakeholders to make informed data-driven decisions about your trials.
Our technology increases enrollment success
Diagnosing autoimmune diseases can be challenging, making enrolling patients in clinical trials difficult. With a fully integrated technology platform like Clinipace’s TEMPO™, viewing and monitoring the number of patients enrolled at every investigator site can give you a real-time look at your enrollment status.
In addition, symptoms are often not present until an advanced stage of disease, making endpoint selection important in designing clinical trials. The use of TEMPO for functions like endpoint adjudication and remote site monitoring reduces cost, improves accuracy, and enables faster study close-out. Real-time data access also enables adaptive study designs that require fewer patients, increases likelihood of successful outcomes, and provides early identification of safety signals.
Globalize your trial and control costs
Given the high costs typically associated with clinical trials, a viable alternative is to conduct trials in developing countries with treatment-naïve patients, where costs per subject are historically lower. Clinipace has operations in countries across the globe and teams with region-specific expertise who can guide your trial to success.
- Infectious DiseaseInfectious Disease
We will address your infectious disease challenges
The development of treatments for infectious diseases poses unique challenges, including resistant bacteria and viruses, enrollment complexities, and waning investigator interest. We can help you navigate these challenges and create opportunities in the evaluation of new agents impacting this unique therapeutic area.
Let our Regulatory and Strategic Development (RSD) experts provide their expertise on the numerous new guidelines issued by the FDA for antimicrobial drug clinical trials, such as requirements for better defined patient populations and microbiologic identification of pathogens, superiority studies required for approvals, and redefining of clinical endpoints.
The increasing threat of ever-evolving infectious diseases has created an immediate need for research and development in this area. Through our TEMPO eClinical integrated platform, we will help you create and execute on a more robust research pipeline.
We can help you design and conduct a more efficient clinical trial for your orthopaedic product, including providing expertise on unique protocol design considerations and deploying the right technology to bring visibility and a level of collaboration and control not possible in a traditional CRO environment.
Our Regulatory and Strategic Development (RSD) and Clinical Operations teams at Clinipace Worldwide can help guide the successful execution of your orthopaedic medical device or therapeutic agent clinical trial. We have expertise in navigating the challenging regulatory pathways, including developing pre-market notification 510(k) and pre-market approvals, obtaining investigational device exemptions, and working directly with the FDA for feedback during the development cycle. With centralized North American, South American, European, and Asian hubs, we can help navigate the nuances of local regulatory and contracting processes and relationships across countries in multinational trials.