Industries
Life Sciences
Life Sciences
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:
Accelerate Business
Improve revenues, drive process efficiencies, ensure quality & compliance and foster innovation.
Unlock Value
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.
- Data Collection & maintenance of global safety data
- Safety medical monitoring of clinical trials
- Protocol waiver and compliance assessment
- Serious adverse events (SAEs) surveillance (24-hour coverage)
- Serious adverse event processing
- Lab data, imaging data, EKG and QTc, safety review
- Medical coding of the cases
- Medical review of the cases
- Medical /QA review
- Drug Safety Monitoring Board (DSMB) management. Endpoint adjudication
- Write DSMB charters and lead DSMBs meetings
- Drug Safety / Pharmacovigilance operation planning and management
- Signal Detection
- Risk Management
- SAE/AE Initial documentation and reporting
- Case Report Characterization
- Epidemiologic Perspective for Marketed Product Reports
- Safety Data Management
- AE and SAE tracking, coding
- SAE case processing
- MedDRA and WHO-DD coding, medical quality review
- AE and SAE causality evaluations
- SAE narrative composition
- MedWatch (FDA 3500A)
- CIOMS I forms
- Preparation of Periodic Safety Update Reports (PSURs)
- Electronic submissions to European authorities
- US FDA
- Canadian Health Authority
- MHLW- Japanese Health Authority
- DCGI- Indian Health Authority
- Develop safety database
- Literature review
- Enhance risk management programs
- Physician medical review and signal detection
- Pertinent literature reviews and summaries
- Post-marketing signaling
- Pharmacoepidemiology
- Pre-registration signaling
- Post-marketing signal assessments; label revision, post-marketing safety studies and design and conduct the registries and clinical trials
- Literature-based drug class perspective evaluation
- Call Center
- Triaging
- Case intake/Data Entry
- Safety narrative writing
- Medical coding
- Assessment of seriousness, causality, and expectedness
- Medical Review
- Regulatory reporting
- Literature Search
- Litigation Cases
- Crisis Management
- Signal Detection
- Risk management
- Aggregate Reporting
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. APLOMB provides Life Sciences companies with end-to-end risk solutions, supporting organizations from the initial discovery phase to final product launch.
- DSMB establishment and management
- Adherence to industry best practices and the ability to replicate successful risk management strategies
- Use of key benchmarking and actuarial analytics to support decision-making for program structures such as limits, retentions and pricing
- A seasoned team of attorneys to offer proven claims advocacy expertise in large product-liability class action and securities class action litigation
- Dedicated claims advocacy and management for complex product liability litigation and securities class actions
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.
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.
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
APLOMB uses right technologies for drug safety data management including proprietary software tools to ensure efficient workflows and streamline processes.
- Drug Safety Data Management
- AE and SAE log-in, tracking, coding and SAE case processing
- MedDRA and WHO-DD coding
- Medical quality review
- AEs and SAEs evaluations
- Generate SAE narrative composition
- Safety medical review and signal detection
- Review publications
- Generate summary
- Regulatory reporting
- Generate MedWatch (FDA 3500A)
- Generate CIOMS I forms
- Prepare Periodic Safety Update Reports (PSURs)
- Prepare periodic adverse drug experience reports (PADERs)
- Prompt notification of IND expeditable and suspected unexpected serious adverse reaction (SUSAR) reports
We offer expertise in post-marketing signaling and Pharmacoepidemiologic techniques:
- Population at risk incidence/prevalence statistics
- Literature review
- Enhance risk management programs
- Physician medical review and signal detection
- Pertinent literature reviews and summaries
- Label revision
- Risk MAPs
- Post-marketing safety studies [PASS] and study design and conduct of registries.
We at Sain Cosmos 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.
CRO Services
- Clinical Operations: A comprehensive and full service operations to support Pre-IND, IND, NDA and beyond the NDA for our customers.
- Data Management & Biostatistics: User-friendly integration of data management tool with highly skilled statistical and medical writing expertise.
- Clinical: Manage clinical professionals; Medical Monitor, Medical Officer Safety, Project Manager, Clinical Research Associate, Medical Writer. High quality and cost effective on-shore and off-shore talents to meet our clinical trial needs.
- Clinical investigators: Provide highly experienced investigators, trained clinical research associates and nursing staff with extensive experience in relevant therapeutic areas.
- Global Clinical Development Plan
- Phase I QTc Trials (PK/PD of Cardiac Repolarization) in Healthy subjects
- Phase I QTc Trials (PK/PD of Cardiac Repolarization) in cancer patients
- Phase I, II, III
- Patient Recruitment
- Clinical Monitoring
- Medical Monitoring
- Trial Management
- Data Management
- Biostatistics
- Medical writing
- Post-Marketing Clinical Trials and trial design
- Phase IIIb and IV
- Life Cycle Management
- Market feasibility analysis
- Investigator Sponsored Trials
- Cooperative Group Trials
- Observational trials and Registries
- KoLs support for publication and additional study design
- Write charters
- Identification of medical readers and reviewers
- Image data management
- Pre-IND meetings, IND preparation
- End of phase 2 FDA meetings
- Investigator Drug Brochures
- FDA intercation
- EU Commission, European countries
- MHLW, Japan
- DCGI, India
- Support IND & NDA submission
- Country selection
- Chief Investigator selection
- Investigators selection
- Contract and budget
- Clinical trial management
- Medical monitoring
- Patients recruitment
- Data management
- Imaging data management
- Central laboratory data management
- Safety data management
- CSR
- Life Cycle and Brand Enhancement
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.
Sain Cosmos offers the following Data Management Services:
- e-CRF and Paper CRF Design and Production
- Electronic and facsimile data capture
- Database Design and Validation
- Interactive drug management and drug supply
- Laboratory data management (Lab, ECG, PK)
- Radiology Images Management
- CRF/Edit Check Log and Tracking
- Query Management, Query Generation and Resolution
- Adverse Event and Concomitant management.
- Safety procedures AEs/SAEs Reconciliation, reporting and management of protocol violations, deviations, and endpoints
- Medical coding using standard dictionaries; MedDRA, WHO-DD, and sponsors dictionaries
- Data validation, review, and cleaning
- Quality Control to highest standards, with Quality Control Management processes and ensure high-quality data
- Management of data of third party vendors, data consolidation and conversion
- Submission and transfer of Data to Sponsor, Regulatory Agency using CDISC standards
Warehousing & Integration of data management software
- I-Review/J-Review
- DsNavigator / ARISg
- Cognos and Crystal Reports
- Clinical Trial Management Systems (CTMS)
- Statistical expertise in study design and Statistical Analysis Plan
Data Management-BPO Model in India
- Strategic control of studies and the Data
- Encapsulation of In-house Knowledge by Sponsor
- Operational Cost Optimization
- Achieving timeline targets
- Efficient use of limited resources
- Standardization of processes
- Data Security & Integrity
- Training Clinical Sites and Investigators for EDC
- Consistency in Deliverables
- Being true partner’s of sponsor.
- Computer access controls: Multi-layered Password, session timeouts
- Audit trails and other login securities
- Date/Time Stamps
- Systems Used for direct data entry and EDC
- System dependability tested continuously
- Copies of records and record inspection maintained securely
- Certification of electronic signatures
Services offering departments:
- Agricultural Science
- Analytical Chemistry
- Anatomy
- Anthropology/Sociology
- Biochemistry
- Bioengineering
- Bioinformatics
- Biology
- Biomedical Engineering
- Biophysics
- Biotechnology
- Botany/Plant Science
- Cancer Research
- Cell Biology
- Biomedical Sciences
- Biophysics
- Biotechnology
- Botany/Plant Science
- Cancer Research
- Cell Biology
- Computational Biology
- Developmental Biology
- Ecology
- Endocrinology
- Environmental Science
- Epigenetics
- Evolutionary Biology
- Genetics
- Genomics
- Immunology
- Marine Science
- Microbiology
- Molecular Biology
- Neuroscience
- Oncology
- Organismal Biology
- Other Life Science
- Pharmacokinetics/Pharmacodynamics
- Pharmacology
- Physiology
- Polymer Science
- Proteomics
- Stem Cells
- Structural Biology
- Veterinary Medicine
- Virology
- Zoology