Secure & Compliant Pharma Back Office Outsourcing
Free up your core teams to focus on R&D and patient outcomes.
We provide AI-powered, HIPAA-compliant support to streamline your operations.
Comprehensive Pharma Back Office Solutions
We offer a full spectrum of AI-enhanced back office services, designed to meet the rigorous demands of the pharmaceutical and life sciences industries. Focus on your core mission while we handle the operational complexities with precision and care.
Clinical Trial Data Management
Ensure the integrity and accuracy of your clinical trial data with our expert management services. We handle everything from data entry and validation to query resolution and database lock, adhering strictly to GCP and 21 CFR Part 11 standards.
- Achieve over 99.9% data accuracy through rigorous, multi-tier quality checks.
- Accelerate study timelines with efficient data processing and real-time reporting.
- Reduce compliance risks with our deep expertise in global regulatory standards.
Regulatory Affairs Support
Navigate the complex global regulatory landscape with confidence. Our team provides comprehensive support for submissions (IND, NDA, MAA), lifecycle management, and regulatory intelligence, ensuring your documentation is compliant and submission-ready.
- Streamline submission preparation to meet critical deadlines with regulatory bodies like the FDA and EMA.
- Maintain a constant state of inspection-readiness with organized and accurate documentation.
- Gain strategic insights into evolving regulatory requirements to proactively manage compliance.
Pharmacovigilance (PV) Case Processing
Our end-to-end pharmacovigilance services ensure timely and accurate processing of adverse event data. From case intake and data entry in safety databases (like Argus) to narrative writing and regulatory reporting, we help you maintain global safety compliance.
- Enhance reporting accuracy and consistency with our standardized, quality-driven processes.
- Improve operational efficiency and scalability to handle fluctuating case volumes.
- Ensure global compliance with all PV regulations and guidelines.
Medical Information Call Center
Provide accurate, timely, and compliant responses to inquiries from healthcare professionals and patients. Our medically trained agents manage product information requests, off-label inquiries, and adverse event reporting with professionalism and empathy.
- Deliver high-quality, consistent medical information across all channels.
- Ensure regulatory compliance in all communications and documentation.
- Improve stakeholder satisfaction with responsive and knowledgeable support.
Revenue Cycle Management (RCM)
Optimize your financial performance with our comprehensive RCM services. We manage the entire lifecycle, from patient registration and benefits verification to claims submission and denial management, maximizing your revenue and cash flow.
- Increase collection rates and reduce days in accounts receivable.
- Minimize claim denials through proactive verification and accurate coding.
- Gain financial clarity with transparent reporting and analytics.
Medical Billing and Coding
Ensure accurate and compliant billing with our certified medical coders. We are proficient in ICD-10, CPT, and HCPCS coding, helping you reduce errors, prevent audits, and accelerate reimbursement from payers.
- Improve coding accuracy to reduce compliance risks and payment delays.
- Maximize reimbursement by ensuring all services are correctly coded and billed.
- Stay current with ever-changing coding regulations and payer requirements.
Supply Chain & Logistics Support
Streamline your pharmaceutical supply chain from procurement to distribution. We provide support for order processing, inventory management, vendor coordination, and logistics tracking to ensure product availability and integrity.
- Enhance visibility and control over your entire supply chain.
- Optimize inventory levels to reduce carrying costs and prevent stockouts.
- Improve efficiency in order fulfillment and distribution processes.
Document Management & Control (eTMF)
Maintain an audit-ready electronic Trial Master File (eTMF) with our meticulous document management services. We handle document collection, indexing, quality control, and archiving, ensuring your clinical trial documentation is complete and compliant.
- Ensure your eTMF is inspection-ready at all times.
- Improve document retrieval efficiency for study teams and auditors.
- Guarantee the completeness and quality of your trial documentation.
Patient Onboarding & Support
Create a seamless and supportive experience for patients joining clinical trials or starting new therapies. Our services include eligibility screening, onboarding coordination, appointment scheduling, and adherence reminders.
- Improve patient recruitment and retention rates in clinical trials.
- Enhance patient satisfaction and adherence to treatment protocols.
- Reduce the administrative burden on your clinical and support staff.
Rebate & Chargeback Processing
Manage complex government and commercial rebate programs with precision. We handle claim validation, processing, and dispute resolution for Medicaid, Medicare, and commercial chargebacks, ensuring accuracy and compliance.
- Improve the accuracy and timeliness of rebate and chargeback processing.
- Minimize revenue leakage from invalid or duplicate claims.
- Ensure compliance with all government pricing regulations.
Sales & Marketing Operations Support
Empower your commercial teams by offloading administrative tasks. We provide support for CRM data management, lead qualification, marketing campaign execution, and sales reporting, allowing your team to focus on selling.
- Improve data quality in your CRM for more effective targeting and reporting.
- Increase the productivity of your sales and marketing teams.
- Gain better insights into commercial performance with accurate analytics.
HR & Payroll Administration
Streamline your human resources and payroll functions. We manage employee data, benefits administration, payroll processing, and compliance reporting, ensuring your internal operations run smoothly and efficiently.
- Ensure accurate and timely payroll processing for all employees.
- Reduce the administrative burden of HR and benefits management.
- Maintain compliance with labor laws and reporting requirements.
Finance & Accounting Outsourcing
Strengthen your financial operations with our expert accounting services. We handle accounts payable/receivable, general ledger accounting, financial reporting, and budget support, providing you with accurate and timely financial insights.
- Improve the accuracy and efficiency of your accounting processes.
- Gain access to timely financial reports for better decision-making.
- Ensure compliance with accounting standards and regulations.
IT Helpdesk Support
Provide your employees with responsive and effective technical support. Our IT helpdesk services cover troubleshooting, software/hardware support, user account management, and incident resolution, minimizing downtime and boosting productivity.
- Increase employee productivity with fast and reliable IT support.
- Reduce the workload on your internal IT team.
- Improve IT service quality with structured processes and reporting.
Procurement & Vendor Management
Optimize your procurement process and manage vendor relationships effectively. We assist with purchase order processing, vendor onboarding and communication, invoice reconciliation, and performance tracking.
- Streamline your procure-to-pay cycle for greater efficiency.
- Improve vendor performance and relationship management.
- Achieve cost savings through better procurement controls and insights.
Your Strategic Advantage in Pharma Operations
We are more than a vendor; we are your partner in achieving operational excellence. Our unique combination of security, expertise, and technology sets us apart and delivers tangible results for your business.
Unbreakable Security
Your sensitive data is protected by our robust, multi-layered security framework. We are SOC 2, ISO 27001, and HIPAA compliant, ensuring your IP and patient data remain confidential and secure.
Pharma Domain Experts
Our teams aren't just BPO professionals; they are trained specialists who understand the nuances of the life sciences industry, from GxP guidelines to complex regulatory requirements.
AI-Powered Efficiency
We leverage AI and Robotic Process Automation (RPA) to automate repetitive tasks, reduce human error, and accelerate processing times, delivering significant cost savings and efficiency gains.
Scalable On-Demand
Whether you're a startup launching your first product or a global leader managing multiple trials, our flexible models allow you to scale your back office support up or down as your needs evolve.
Proven CMMI 5 Process
Our CMMI Level 5 certified processes guarantee the highest level of quality, consistency, and continuous improvement in every task we perform, minimizing risks and maximizing performance.
Cost Reduction Focus
Achieve up to 60% reduction in your operational costs without compromising on quality. Our efficient delivery model from India provides access to top-tier talent at a competitive price point.
Dedicated Account Mgmt
You get a single point of contact dedicated to your success. Our account managers ensure seamless communication, transparent reporting, and proactive problem-solving.
24/7 Global Support
Our operations run around the clock, providing you with the support you need, whenever you need it, across different time zones to keep your global operations moving forward.
Risk-Free Trial
Experience our quality and efficiency firsthand. We offer a 2-week paid trial and a free replacement guarantee, giving you complete peace of mind when you partner with us.
Proven Success in the Life Sciences Sector
Don't just take our word for it. See how we've helped pharmaceutical and biotech companies overcome their operational challenges and achieve their strategic goals.
Accelerating Clinical Trials for a Mid-Sized Biotech Firm
Industry: Biotechnology
Client Overview: A rapidly growing biotech company with a promising drug candidate was struggling to manage the high volume of data from their Phase III clinical trials. Their small in-house team was overwhelmed, leading to delays in data cleaning and analysis, which threatened their submission timeline.
"LiveHelpIndia's team became an extension of our own. Their accuracy and speed in handling our clinical data were exceptional, allowing us to lock our database weeks ahead of schedule. They are a true partner."
- Dr. Eleanor Vance, COO, Innovate BioPharma
Our Solution:
We deployed a dedicated, GCP-trained team to handle all aspects of their clinical data management. This included data entry from CRFs, running validation checks, managing data queries with clinical sites, and performing SAE reconciliation. We established a secure, 24/5 workflow to ensure continuous progress.
Streamlining PV Case Processing for a Global Pharma Leader
Industry: Pharmaceuticals
Client Overview: A top-10 pharmaceutical company was facing challenges with their global pharmacovigilance operations. High costs, inconsistent quality across regions, and difficulty scaling to meet fluctuating case volumes were impacting their compliance and efficiency.
"The AI-powered workflow designed by LiveHelpIndia transformed our PV operations. We've seen significant cost savings and a dramatic improvement in the consistency and speed of our case processing. Their expertise is world-class."
- Marcus Thorne, Global Head of Pharmacovigilance, OmniCure Pharmaceuticals
Our Solution:
We implemented a hybrid solution combining a managed team of PV specialists with an AI-powered automation platform. The AI handled initial case intake and data extraction, while our team focused on medical assessment, narrative writing, and quality review. This created a highly efficient, scalable, and cost-effective global PV hub.
Scaling Post-Launch Support for a Medical Device Innovator
Industry: Medical Devices
Client Overview: A medical device startup received FDA approval for their innovative wearable device and needed to rapidly establish a 24/7 technical and patient support center. They lacked the infrastructure and personnel to handle the anticipated volume of inquiries from both patients and healthcare providers.
"Launching a new device is chaotic. LiveHelpIndia gave us a turnkey support solution that was professional, empathetic, and scalable from day one. Our customers love the support they receive, which has been key to our successful launch."
- Sarah Jenkins, CEO, NextGen MedTech
Our Solution:
We set up a dedicated, multilingual 24/7 support desk within two weeks. The team was trained on the device's technical specifications and clinical use cases. We managed all channels, including phone, email, and live chat, handling everything from device troubleshooting to patient onboarding and adverse event intake, which was then routed to their PV team.
Technology & Platforms We Master
Our teams are proficient in the leading software and platforms used across the life sciences industry, ensuring seamless integration with your existing technology ecosystem.
What Our Clients Say
Our 95%+ client retention rate is a testament to the trust we build and the results we deliver. Hear directly from leaders who have transformed their operations with LiveHelpIndia.
"Outsourcing our regulatory submissions support to LiveHelpIndia was a game-changer. Their attention to detail and understanding of eCTD requirements is second to none. We met our submission deadline with zero validation errors."
"As a biotech startup, every dollar counts. LiveHelpIndia provided a cost-effective solution for our back-office needs without sacrificing quality. Their team is proactive, responsive, and truly invested in our success."
"The security and compliance protocols at LiveHelpIndia gave us the confidence to outsource our patient data processing. Their HIPAA-compliant framework is robust, and their team operates with the utmost professionalism."
"We needed to scale our medical information call center quickly. LiveHelpIndia had a trained team ready to go in weeks. The quality of their agents is outstanding, and our HCP satisfaction scores have increased by 20%."
"Their RCM team has been instrumental in improving our cash flow. They are experts at navigating the complexities of medical billing and have significantly reduced our claim denial rate. I highly recommend them."
"The level of transparency and communication is what sets LiveHelpIndia apart. Through their dashboards and regular reporting, I always have a clear view of our outsourced operations' performance."
Frequently Asked Questions
Have questions? We have answers. Here are some of the most common inquiries we receive from prospective clients in the pharmaceutical and life sciences sector.
Data security is our top priority. We are ISO 27001 certified and SOC 2 compliant, with robust technical and administrative safeguards. All our pharma services are governed by a strict HIPAA compliance framework, which includes regular employee training, encrypted data transmission and storage, access controls, and routine security audits.
Our teams undergo rigorous, domain-specific training. They are well-versed in GxP (GCP, GMP), 21 CFR Part 11, and the specific guidelines of regulatory bodies like the FDA and EMA. We have dedicated quality assurance teams to ensure all work meets these exacting standards.
We follow a structured, four-phase process: 1) Discovery & Scoping, 2) Process Mapping & SOP Development, 3) Team Training & Knowledge Transfer, and 4) Go-Live & Hypercare Support. A dedicated transition manager oversees the entire process to ensure a smooth and seamless handover with minimal disruption to your business.
Absolutely. Scalability is a core component of our service offering. We can quickly ramp up or down the size of your dedicated team, typically within 2-4 weeks, to accommodate fluctuations in workload, such as increased case volumes during a product launch or scaling down after a clinical trial concludes.
We provide complete transparency. You will receive access to a customized performance dashboard with real-time data on key metrics (e.g., turnaround time, quality scores, volume processed). We also conduct regular governance meetings (weekly, monthly, and quarterly) to review performance, discuss challenges, and align on strategic goals.
Ready to Optimize Your Pharma Operations?
Let's discuss how our secure, compliant, and AI-powered back office solutions can reduce your costs and free you to focus on what matters most: innovation and patient health. Schedule a no-obligation consultation with our experts today.
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