Consulting & Regulatory Partners
Many drug developers have limited resources when it comes to conducting clinical trials. The lack of resources requires them to seek the knowledge and expertise of qualified clinical consultants. The experience provided by consultants can include regulatory, due diligence, study design, protocol development, vendor management, site selection, patient recruitment, and audits.
How can we help?
Looking for help with finding Consulting & Regulatory Partners? If you're searching for information or a supplier, let Clinical Leader lend you a hand.
Actigraph
ActiGraph's mission is to bring life to digital data. Built on more than twenty years of remote data capture expertise, ActiGraph is the leading provider of medical-grade wearable motion sensors for the global scientific community. ActiGraph's FDA-cleared biosensors and flexible technology ecosystem deliver high quality, continuous digital data, providing valuable insights into the real-world behaviors of clinical trial participants.
Capabilities
Advarra
Advarra's team of industry and regulatory experts provides outcome-oriented solutions that help organizations overcome challenges related to regulatory submissions, quality management, clinical trial design and execution, as well as research administration and compliance. With a proven track record of success, Advarra's consultants bring their extensive hands-on experience and expertise to help clients bring life-changing therapies to market with confidence.
Capabilities
Altasciences
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services.
Have questions about finding Consulting and Regulatory Partners?
The Clinical Leader team can help. We'll match your needs with the right companies.
Contact us via email for assistance.
Bioforum
Bioforum is a data-focused contract research organization (CRO), serving clients worldwide in optimizing the collection, standardization, and reporting of clinical research data. We strive to consistently improve and innovate data processes, enabling the most efficient data submissions for our clients across the life sciences industry worldwide. Our multidisciplinary team provides in-depth expertise and delivers high-quality solutions, including medical writing, data management, biostatistics and statistical programming.
Capabilities
CMIC Group
CMIC was founded in 1992 as the first CRO in Japan. To enable pharmaceutical companies to develop better medicine sooner, we expanded our solutions to include contract development and manufacturing, site support, and market solutions, supporting global companies to bring highly desired treatments to the Japanese market, to consult and conduct Asia clinical trials, or to bridge drug development and manufacturing needs between the US and Japan.
Capabilities
CRIO
CRIO, the leader in eSource technology, is transforming clinical research with the latest in cloud technology. CRIO's eSource system enables remote monitoring and immediate data review with a powerfully integrated eSource/EDC solution. CRIO delivers data only once - at the moment of immediacy - without re-entering into EDC, and protects data integrity with built-in compliance across 21 CFR 11, ICH-GCP, GDPR, HIPAA, and other global regulations.
Florence Healthcare
Florence accelerates clinical research with innovative solutions to streamline clinical trial site workflows and remote connect sponsors, CROs, and sites for access, monitoring, management, and SDR/V. The Florence platform is the industry standard with more than 7,200 research sites in 27 countries, sponsors and CROs collaborating on its network.
Capabilities
Harbor Clinical
Harbor Clinical is a women-owned clinical research services firm with headquarters in the Boston biotech area. As a Functional Service Provider (FSP) offering Staff Augmentation, Consulting, and Single-Service resourcing models, Harbor Clinical's mission is based on the goal of forging innovative partnerships, with sponsors and employees, built on a bedrock of communication and transparency.
Capabilities
inSeption Group
inSeption distinguishes people as the most impactful variable in the outsourcing equation. Our path-breaking model attracts biopharma companies who demand a partner that shares in their drive to conduct impeccable development and will provide quality and dependable clinical solutions. We offer full outsourcing, consulting services, and functional service provider (FSP) solutions.
Capabilities
IQVIA Integrated Global Compliance
IQVIA Integrated Global Compliance offers a complete lifecycle approach that brings together safety, regulatory, quality, and medical information to transform how life sciences companies sustain compliance and how compliance functions perform better together.
By integrating services, technology, and analytics, we can help bring together disparate compliance functions, resulting in heightened patient safety, improved compliance performance, and proactive insights power by IQVIA Connected Intelligence.
Capabilities
Novotech
Novotech is the leading Asia Pacific centred biotech CRO with global execution capabilities. Novotech is a clinical CRO with labs, phase I facilities, drug development consulting services and FDA regulatory expertise and has experience in over 3,700 pre-clinical and clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biotech clients conducting clinical trials in Asia Pacific, the US and Europe.
Capabilities
OCT Clinical
OCT is the leading contract research organization in Russia. Since 2005, OCT's team has conducted over 300 clinical trials in 29 therapeutic areas in Eastern Europe and the CIS region. Our team of 150+ clinical professionals provides a full range of high-quality CRO services for Phase I-IV and BE studies, with therapeutic expertise in oncology, infectious disease, and all major therapeutic indications.
Phlexglobal
Phlexglobal is the leading technology and services organization for clinical and regulatory matters with a focus on helping master a digital agenda via proven AI solutions. Phlexglobal combines software and services to offer a unique solutions portfolio with easy to achieve automation via data generation for a new level of effectiveness. The company's Trial Master File software and Regulatory Solutions are considered highly innovative in the industry.
Capabilities
Premier Consulting
Premier Consulting is a strategic product development and global regulatory consulting business unit of Premier Research, dedicated to supporting the specialized needs of emerging biotech, specialty pharma, and MedTech companies. We are informed by our Built for BiotechSM and Made for MedTechTM core capabilities to deliver end-to-end strategy, regulatory, nonclinical, CMC, quality, clinical, and commercial expertise.
Please Contact Us to schedule a meeting or request more information.
Capabilities
Premier Research
Premier Research believes in a holistic approach to clinical development. From regulatory consulting, to product development, to innovative study designs and patient-centric solutions, we consider your study from every angle to maximize success. Our Built for Biotech℠ model is rooted in flexibility, and we are dedicated to helping the most innovative biotech, specialty pharma and medtech companies take their best ideas from concept to commercialization.
TransPerfect
For over 20 years, TransPerfect has helped life sciences companies conduct clinical development and commercialize products on a global scale. We bring that same level of expertise to our secure, web-based e-clinical solution, Trial Interactive. Trial Interactive enables life sciences companies to streamline the execution and commercialization of global clinical trials and collaborate on partnerships while reducing administrative burdens.
Veristat Inc.
Veristat, a global clinical research organization (CRO), enables sponsors to solve the unique and complex challenges associated with accelerating therapies through clinical development to regulatory approval. With more than 26 years' experience in clinical trial planning and execution, Veristat is equipped to support any development program. Our team has prepared over 100 marketing applications for approval with global regulatory authorities in the last 10 years alone.
Capabilities
YPrime
YPrime's cloud-based technology streamlines clinical trial data collection and management. YPrime's eCOA and interactive response technology (IRT) platforms introduce greater speed, precision, and data quality to clinical trials. Our consulting services help clients simplify downstream processes, while moving faster and more efficiently to their next development milestone.
Capabilities