Replace administrative overhead with AI-driven efficiency. Our managed back office services for Pharmacovigilance, Regulatory Affairs, and Clinical Data are secure, GxP-compliant, and built to scale with you.
Request A Free ConsultationIn the pharmaceutical and life sciences industry, every dollar and every minute saved on administrative tasks is a resource you can redirect to research, development, and getting treatments to market faster.
Yet, managing the fluctuating back-office workload for clinical trials, regulatory submissions, and pharmacovigilance is a constant drain on your budget and your experts' time.
LiveHelpIndia provides a solution: specialized, AI-enabled back office teams that integrate seamlessly with your operations. We handle the process-driven work with precision and compliance, so your scientists can focus on science. It's not just outsourcing; it's strategic operational scaling.
Scaling a pharma operation is complex. When administrative overhead, compliance gaps, and resource constraints collide, the result is delayed milestones and ballooning costs. We identify these friction points to clear your path forward.
Every dollar spent on non-core administrative overhead is capital pulled away from R&D. Managing complex back-office workflows in-house often leads to inefficient spending that dilutes your clinical impact and forces budget trade-offs.
Clinical trial phases are dynamic. Relying on a fixed internal team often means you are either overstaffed during lulls or critically understaffed during peak trial phases, creating costly bottlenecks that jeopardize your study timelines.
Your researchers and scientists were hired to innovate, not to manage data entry, regulatory documentation, or adverse event reports. When experts are burdened with administrative tasks, their focus shifts from breakthrough science to routine processing.
Navigating GxP, HIPAA, and evolving global regulations requires specialized, continuous expertise. Relying on generalist teams or manual processes creates high-risk compliance vulnerabilities that can lead to audit failures and regulatory scrutiny.
From clinical data management to regulatory compliance, our AI-enabled teams provide the operational backbone for your life sciences projects. We deliver scalable, GxP-compliant expertise tailored to your specific requirements.
We manage the end-to-end lifecycle of Individual Case Safety Reports (ICSRs). Our AI-assisted teams handle case intake from all sources, data entry into safety databases (like Argus), MedDRA coding, narrative writing, and quality control, ensuring timely and accurate regulatory reporting.
Our medical writing team supports the preparation of periodic safety reports, including PADERs, PSURs/PBRERs, and DSURs. We assist with data compilation, analysis, and authoring sections of the reports, freeing up your senior safety physicians for strategic review.
We conduct systematic literature searches in databases like PubMed and Embase to identify potential ICSRs and safety signals as required by global regulations. Our team screens articles, assesses for reportability, and processes valid cases.
Our data specialists provide support for signal detection activities. We help prepare data for analysis, run routine reports from your safety database, and track signals through the validation and assessment process, providing crucial support to your safety management team.
We provide comprehensive support for electronic Common Technical Document (eCTD) publishing. Our team handles document formatting, hyperlinking, and compilation using industry-standard software, ensuring your submissions to agencies like the FDA and EMA are technically valid and on time.
We manage and maintain your regulatory document repository, including Trial Master Files (eTMF). Our team handles document classification, indexing, quality control, and archival, ensuring your records are complete, accurate, and inspection-ready at all times.
Our team provides administrative and quality control support for your global labeling process. We assist with tracking labeling changes, proofreading artwork against source documents, and managing the repository of approved labels, ensuring accuracy and compliance.
We provide high-volume, high-accuracy clinical data entry from paper or electronic Case Report Forms (CRFs) into your Clinical Data Management System (CDMS). Our AI-powered QC processes ensure data integrity from the start.
Our data specialists perform meticulous reconciliation between clinical and safety databases to ensure consistency in adverse event reporting. This critical step is essential for regulatory compliance and data integrity for your clinical study report.
We manage the operational side of the data query process. Our team can generate, track, and manage data queries in your CDMS based on predefined rules, facilitating communication between data managers and clinical sites to resolve data issues quickly.
We provide first-line medical information support for healthcare professionals and patients. Our trained agents handle product inquiries, document requests, and triage calls for adverse event reporting or product quality complaints according to your approved scripts and SOPs.
Our multi-channel contact center acts as your central point for AE and PC intake. We capture critical information via phone, email, and web forms, ensuring all reports are documented accurately and triaged to the appropriate department (PV or QA) immediately.
Our team assists in developing and managing medical and scientific content. This includes formatting manuscripts for journal submission, creating slide decks from clinical data, and managing reference libraries, supporting your medical communications and publications teams.
We support Real-World Evidence (RWE) and Health Economics and Outcomes Research (HEOR) projects by abstracting specific data points from patient charts, EMRs, or publications. Our teams are trained to find and record data with high accuracy for your research needs.
We provide independent QC services for a wide range of back-office deliverables. This includes QC of clinical data, safety case narratives, regulatory documents, and more. Our QA support helps review processes and identify areas for improvement.
"LiveHelpIndia didn't just give us bodies; they gave us a fully-managed, expert PV team overnight. We went from panic to complete control. Their process and quality were flawless, and we passed our first regulatory inspection without a single finding in PV. The cost savings were just the icing on the cake."
"The LHI team became our publishing engine. We now send them the final documents and get back a submission-ready eCTD sequence within 48 hours. It's completely changed our workflow. Our regulatory experts are now 100% focused on strategy, and we've never missed a deadline since."
"LiveHelpIndia brought a level of process excellence and transparency we hadn't seen from other BPOs. Their CMMI Level 5 approach, combined with smart AI tools for QC, delivered not only the significant cost savings we needed but also a surprising jump in data quality. They are a true strategic partner."
Operate with confidence. Our processes are built on a foundation of GxP, HIPAA, and 21 CFR Part 11 principles. With CMMI Level 5, SOC 2, and ISO 27001 certifications, we ensure your operations are audit-ready from day one, mitigating your regulatory risk.
Reduce your back-office operational costs by up to 60%. Our AI-augmented global delivery model eliminates the high overhead of in-house teams, including salaries, benefits, IT, and facilities, freeing up critical capital for innovation.
Stop paying for idle resources. We enable you to scale your team—from one specialist to over a hundred—in response to clinical trial phases, M&A activity, or new project demands. You get the exact expertise you need, precisely when you need it.
Move beyond manual error. We leverage AI for intelligent data extraction, automated quality control, and case processing, significantly increasing accuracy and consistency while reducing turnaround times for critical tasks like adverse event reporting.
You're not hiring generalists. Our teams are composed of life sciences professionals trained in pharmacovigilance, regulatory affairs, and clinical data management. They understand the terminology, the stakes, and the processes unique to your industry.
Eliminate the 'black box' of outsourcing. You get a dedicated manager, customized SOPs, and 24/7 access to real-time performance dashboards. We operate as a seamless, accountable extension of your own team, providing complete visibility and control.
Your intellectual property and patient data are your most valuable assets. We protect them with multi-layered security protocols, including end-to-end encryption, secure facilities, and AI-powered threat detection, ensuring total confidentiality and integrity.
Get operational in weeks, not months. Our proven transition methodology ensures a smooth, disruption-free handover of processes. We handle all training, knowledge transfer, and system setup, allowing your team to stay focused on their core responsibilities.
Rely on uninterrupted service. Our global delivery centers and robust infrastructure provide built-in redundancy, ensuring your critical back-office functions continue running 24/7/365, regardless of local disruptions or staff turnover.
We don't just "take over" work. We map, measure, and manage your processes to ensure absolute business continuity. Our 5-stage transition methodology eliminates the "black box" risk of outsourcing by codifying your tribal knowledge into scalable, GxP-compliant workflows.
We begin by auditing your current operational environment. Our senior delivery leads work directly with your subject matter experts to document every step, decision point, and exception in your existing workflows. We identify bottlenecks, data silos, and compliance risks before we touch a single line of data.
Knowledge is useless if it's only in your team's heads. We convert your tribal knowledge into rigid, audit-ready Standard Operating Procedures (SOPs). We align these documents with GxP, 21 CFR Part 11, and your specific corporate governance policies to ensure the transition is technically and legally sound.
We never launch at 100% capacity on day one. We start with a controlled pilot phase, processing a subset of live cases or documents under the supervision of your team. This allows us to calibrate our AI tools, fine-tune the communication loops, and prove our accuracy metrics before moving to full-scale operations.
Once the pilot hits our agreed-upon KPIs, we ramp up to full production. You are assigned a dedicated Delivery Manager who serves as your single point of accountability. We implement real-time dashboards that give you 24/7 visibility into performance, quality scores, and resource utilization.
We don't settle for "steady state." Every quarter, we review our performance metrics to identify opportunities for automation. We feed these insights back into our AI models to further reduce manual effort, improve accuracy, and lower your costs continuously. We are committed to making your operations faster and smarter every month.
We leverage a robust suite of industry-standard technologies and certified processes to ensure precision, compliance, and efficiency in every project.
Expertise in Oracle Argus Safety, ArisGlobal LifeSphere, and Veeva Vault Safety is critical for managing case processing and safety reporting workflows efficiently.
Proficiency in Veeva Vault RIM and similar platforms is essential for managing regulatory submissions, correspondence, and product registrations globally.
Deep knowledge of Veeva Vault eTMF, Phlexglobal PhlexEview, and other Trial Master File systems ensures your clinical trial documentation is always inspection-ready.
Mastery of tools like Lorenz docuBridge, Extedo eCTDmanager, and Adobe Acrobat is required for creating technically compliant electronic submissions for health authorities.
Experience with Medidata Rave, Oracle Clinical, and other CDMS platforms is fundamental for managing clinical trial data, from CRF design to database lock.
A foundational understanding of Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GVP), and Good Documentation Practices (GDP) is non-negotiable for regulatory compliance.
Ensures that all electronic records and signatures are managed in a way that is trustworthy, reliable, and considered equivalent to paper records by the FDA.
Guarantees the privacy and security of Protected Health Information (PHI) and personal data, a critical requirement when handling patient-level information.
Proficiency in these standardized medical terminologies is essential for accurate and consistent coding of adverse events and concomitant medications in safety databases.
Knowledge of CDISC standards ensures clinical trial data is structured consistently, facilitating regulatory review and data sharing.
This certification is proof of a systematic and robust approach to managing sensitive company and customer information, ensuring data security.
A SOC 2 report provides assurance about the security, availability, and confidentiality of our systems, which is crucial for building client trust.
The highest level of process maturity, indicating our processes are not just defined and managed, but are continuously and quantitatively improved, leading to higher quality and efficiency.
Our use of AI/ML for tasks like data extraction and QC demonstrates a commitment to innovation and efficiency beyond simple labor arbitrage.
We use RPA to automate repetitive, rules-based tasks like data migration and report generation, which reduces errors and frees up human experts for higher-value work.
Our partners rely on us to deliver operational excellence, compliance, and scalability in their most critical back-office functions.
"The financial impact was immediate and significant. By outsourcing our PV and regulatory document management to LiveHelpIndia, we cut our projected G&A spend by over 50%. Their pricing is transparent, and the quality is exceptional. It's the smartest budget decision I've made."
"I was skeptical about losing control, but LHI's process is the opposite. The transparency is incredible. Their team functions as our own. They scaled up for a major study in two weeks, something that would have taken us three months. They're reliable, professional, and just get it done."
"Our primary concern was compliance. LiveHelpIndia's team came prepared with a deep understanding of GxP and ISO 13485. Their documentation is meticulous, and their processes are genuinely audit-ready. They passed our internal audit with flying colors. I sleep better at night knowing they're handling our complaint intake."
"As a startup founder, my team needs to be 100% focused on our science. LiveHelpIndia took all the administrative weight—regulatory submissions, safety reporting—off our shoulders. They are more than a vendor; they're a strategic partner enabling our growth."
"The speed and accuracy of their eCTD publishing team are unmatched. We throw complex, last-minute submissions at them, and they deliver perfectly compiled, technically valid sequences every single time. They've become an indispensable part of our submission process."
"The quality of the data entry and query management from the LiveHelpIndia team has been outstanding. The AI-powered QC catches things even our manual checks used to miss. Our data cleaning cycles are shorter, and our statisticians are much happier."
See how our managed outsourcing model delivers more value, less risk, and faster results compared to building and managing an internal team.
| Factor | LiveHelpIndia Managed Services | In-House Team |
|---|---|---|
| Cost | Up to 60% lower OpEx. Predictable monthly fee with no hidden costs. No capital expenditure. | High fixed costs: salaries, benefits, taxes, office space, IT hardware, software licenses. |
| Scalability | Elastic. Scale team size up or down in weeks with one phone call. Pay only for what you need. | Rigid and slow. Hiring and training takes months. Downsizing is difficult and costly. |
| Expertise | Access to a deep pool of specialists in PV, Reg Ops, and CDM. CMMI 5 process excellence. | Limited to the skills of current employees. Difficult and expensive to hire for niche skills. |
| Focus | Allows your core team to focus 100% on science, strategy, and innovation. | High-value experts are often distracted by administrative tasks and people management. |
| Compliance & Security | Guaranteed audit-readiness with ISO 27001, SOC 2, and GxP-aligned processes. | Compliance burden falls entirely on you. Requires significant investment in systems and training. |
| Business Continuity | Built-in redundancy with global delivery centers. 24/7 operations and zero downtime. | Vulnerable to staff turnover, sick leave, and local disruptions. Single point of failure. |
Clear, honest answers to help you make an informed decision for your organization.
We have a rigorous hiring process that vets for both technical skills and domain knowledge. All new hires undergo an intensive 6-week training program covering global regulations (GxP, HIPAA), our certified processes (CMMI, ISO), and client-specific SOPs. Training is continuous, with regular assessments and updates to ensure their knowledge is always current.
We use a proven, phased transition methodology. It begins with a discovery phase where we map your existing processes and SOPs. We then move to a 'reverse shadow' phase where our team performs the work with your team overseeing. This is followed by a pilot phase before we go fully live. The entire process is managed by a dedicated transition manager to ensure it is seamless and disruption-free.
Data security is paramount. We are ISO 27001 and SOC 2 certified. Our security measures include secure facilities with biometric access, end-to-end data encryption, firewalled networks, and a strict 'clean desk' policy. All employees are full-time staff who have passed background checks and signed comprehensive NDAs.
Absolutely. Our teams are experienced with all major industry platforms, including Oracle Argus, ArisGlobal LifeSphere, Veeva Vault (eTMF, RIM, Safety), and various CDMS like Medidata Rave and Oracle Clinical. We can work directly within your systems via secure remote access or establish secure data transfer protocols.
A typical governance model includes a dedicated LHI Delivery Manager as your single point of contact for all operational matters. We establish daily check-ins, weekly operational meetings, and monthly/quarterly business reviews (QBRs) with your leadership to discuss performance against KPIs, quality metrics, and strategic initiatives. The framework is customized to your needs.
Our primary model for ongoing support is a fixed monthly fee per full-time equivalent (FTE), which is all-inclusive of salary, management, IT, and infrastructure. This provides predictable budgeting. For defined projects, we offer a fixed-price model based on a statement of work. We also have flexible, on-demand models for ad-hoc needs. Contact us for a custom quote based on your specific requirements.
Yes. We operate 24/7/365 across global delivery centers, ensuring your pharmacovigilance and regulatory tasks never pause. Whether you need support during off-hours, weekends, or across different time zones, our team maintains continuous coverage to meet your critical reporting timelines.
We treat your audit as our own. We provide full documentation, dedicated support staff available during the inspection to answer questions, and proactive process validation to ensure your team is ready. Our CMMI Level 5 and ISO certifications are tangible proof of our commitment to audit-ready compliance.
AI is our assistant, not our replacement. We use it for high-speed tasks like data extraction, automated quality checks, and process routing. However, the final, critical decision-making remains firmly in the hands of our trained, human domain experts who possess the nuanced understanding required in the life sciences sector.
We win your loyalty through performance, not restrictive contracts. If your needs change or if we aren't delivering, we have a clear, documented exit plan. We ensure a seamless handover of all data, knowledge, and documentation back to your team or a successor, ensuring zero disruption to your business operations.
You aren't just hiring a BPO; you're gaining a leadership team dedicated to your operational excellence. Our experts bring decades of experience in life sciences, regulatory compliance, and process engineering to ensure your business thrives.
Founder & CEO
Expert Enterprise Growth Solutions - For Startups and SMEs to Large Organizations. Dedicated to building scalable, high-impact operational frameworks that accelerate your time-to-market.
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Expert Enterprise Technology Solutions - For Startups and SMEs to Large Organizations. Focused on the seamless integration of AI and human expertise to optimize your back-office workflows.
V.P.
Ph.D., FinTech, DeFi, Neuromarketing. Applying rigorous academic research and advanced behavioral science to enhance our delivery models and client interactions.
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Certified Customer Experience; BPO, KPO Services. Deeply specialized in managing complex back-office outsourcing engagements with a focus on compliance and quality assurance.
We believe the future of BPO is not just about cost savings, but about creating intelligent, automated processes that drive superior outcomes. Our investment in AI is a core part of our strategy to deliver increasing value to our pharmaceutical partners. Here's how we're putting AI to work for you today and where we're headed tomorrow.
Ideal for: Clients needing ongoing, scalable support for core functions like PV, CDM, or Regulatory Ops.
Timeline: Onboarding in 2-4 weeks.
Commercials: Monthly fixed fee per FTE. The most cost-effective model for long-term needs.
Ideal for: One-time projects with a defined scope, such as eTMF remediation, a large submission, or legacy data migration.
Timeline: Varies based on project scope.
Commercials: Fixed-fee pricing for the entire project, providing budget certainty.
Ideal for: Clients with fluctuating or unpredictable workloads who need access to specialized skills on an as-needed basis.
Timeline: Setup in <1 week; tasks completed on-demand.
Commercials: Pay-as-you-go or retainer-based model, offering maximum flexibility.