In a fast-changing industry landscape, the life sciences industry is battling challenges, namely, falling R&D productivity, patent cliffs, increased regulations, margin pressures, price-sensitive markets and industry consolidation. Our offering addresses these and works in a seamless continuum to help you:
Improve revenues, drive process efficiencies, ensure quality & compliance and foster innovation.
Continuous process improvement, lower costs with higher productivity, reliable steady state. Our Healthcare & Life Sciences business unit combines domain focus, best-of-breed technology and delivery excellence in a comprehensive portfolio of services equipped to address the demands of rapidly-modernizing industries. We have an unwavering commitment to long-term relationships and our customers include leading pharmaceutical enterprises.
We work with you to drive expertise and momentum to your business:
We spur innovation to bring you reduction in bio-marker discovery times, faster drug discovery cycles, higher collaboration amongst R&D teams and optimization of R&D budgets. We work to bring you enhanced patient outcomes, reduce risk of treatment and lower cost of care. We address your needs of improved visibility and brand awareness, smart launch sequencing, better response to market events, better pricing models and improved field effectiveness.
Organizations in the life sciences industries must comply with the Computer System Validation (CSV) requirement that is issued from the FDA. The regulation mandates that companies in the life sciences industries have the specific controls and procedures in place to consistently produce results that meet its predetermined specification and quality attributes.
Blue Creek Corp brings a thorough understanding of this requirement and a practical risk-based approach to CSV and helps enable life science customers to meet global regulatory requirements, eliminating the GxP compliance risk. Our highly qualified and experienced consultants have real-world domain experience and have the right capabilities and tools to tackle ERP, manufacturing, laboratory, and clinical systems.
Blue Creek Corp’s CSV compliance services include:
Blue Creek Corp provides effective global regulatory affairs services for all stages of pharmaceutical, biologic and medical device product development and lifecycle management.
With interdisciplinary teams and extensive internal resources, Blue Creek Corp's global regulatory affairs staff is flexible and responsive to your needs. Our regulatory consulting services include:
Blue Creek Corp’s CSV compliance services include:
Life Sciences companies face numerous and unique challenges as their life cycles evolve. How these risks are mitigated and identified can be the fundamental difference between financial success and business failure. Blue Creek Corp provides Life Sciences companies with end-to-end risk solutions, supporting organizations from the initial discovery phase to final product launch.
Patient safety is the greatest priority when conducting clinical trials. Our extensively trained medical staff (MDs, RNs, and PAs) work closely with clients, internal teams and investigator sites to ensure strict adherence to all protocols, as well as GCP/ICH guidelines. Our medical safety officers are available to the investigators and investigators sites and the study team, 24 hours a day globally.
Our Medical Affairs team plays an instrumental role in trials of all sizes and varying complexities. Because we have successfully worked on complicated clinical trials, we have the staff, expertise and equipment to handle the most difficult trials.
Medical Monitoring & Consulting services are designed to address each program’s unique requirements including baseline consultations, monitoring and/or further evaluation related to certain medical conditions following exposure to a product or environment. We design and administer each program to fit the specific terms and/or requirements of the parties, ranging from baseline evaluation to additional diagnosis to further procedures or benefits. Extensive monitoring programs can encompass thousands of prospective claimants and hundreds of medical service providers, and may require monitoring and reporting for several years beyond the initial exposure.
Serious Adverse Event (SAE) Data-Capture system is critical for any project. With our Safety Management System, safety data is at your finger tips and is maintained in a tightly controlled, monitored database. Your data will be available for safety personnel to review at any time, world-wide. The system itself is rol- based and allows each client to customize their process flow whether you want the QDS Safety Team or your own to interact with sites and regulatory authorities for the collection and reporting of SAEs.
Our Safety Team is comprised of nurses and physicians with years of clinic and industry related experience. The team uses the Safety Management component to manage all of your safety information needs. Our experienced staff is dedicated to collecting initial information, and all required follow-up information, for complete safety services, while their responsive nature allows for real time-decisions
Blue Creek Corp uses right technologies for drug safety data management including proprietary software tools to ensure efficient workflows and streamline processes.
We offer expertise in post-marketing signaling and Pharmacoepidemiologic techniques:
We at Blue Creek Corp have experienced clinical/medical writers with specific therapeutic areas with relevant medical degrees who are experts in medical assessment, risk assessment and interpretation with clinical/medical judgment. We create aggregator reports as per the guidelines of the regulatory agency for aggregate report writing of EU RMP/RiskMAPs/REMS/PIPs, SUSAR, PSUR, PADER, ASR, DSUR, SBR and other aggregate reports.
Clinical trials are prospective biomedical or behavioral research studies on human subjects that are designed to answer specific questions about biomedical or behavioral interventions (novel vaccines, drugs, treatments, functional foods, dietary supplements, devices or new ways of using known interventions), generating safety and efficacy data. They are conducted only after satisfactory information has been gathered that satisfies health authority/ethics committee approval in the country where approval of the therapy is sought.
Depending on product type and development stage, investigators initially enroll volunteers and/or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. As positive safety and efficacy data are gathered, the number of patients typically increases. Clinical trials can vary in size, and can involve a single research entity in one country or multiple entities in multiple countries. We provide the following solutions.
It’s tough to say goodbye to legacy applications and data. Most businesses keep them around for “just in case†access to data that might be essential for research, litigation, or compliance. But managing and retaining all that data is expensive. And if not done well, it can expose your business to potential liability and risk.
With a reach across the length and breadth of the country and an ISO 9001:2008 compliant service delivery mechanism, we deliver services that result in customer success stories through a collaborative approach with our clients. Our capabilities in large scale process management services across industry verticals is making us a partner of choice for leading organizations in the country.
