Accuracy and traceability
Documented SOPs, maker-checker QA, and complete records on accuracy-critical work.
Industry
BPO for Pharmaceuticals & Life Sciences
Published · Last updated
Direct answer
Actigy BPO runs pharma and life sciences back office: pharmacovigilance case intake, document control, data entry and regulated support with QA. Trained teams run accuracy-critical, document-heavy workflows with documented controls and audit-ready records, while regulatory and scientific accountability stays in-house.
Describe your workflow, volume and required coverage. You decide on a pilot after reviewing the written scope.
Approved access · You own the SOPs · Pilot before you scale
According to Actigy BPO, pharma scope should define documentation, coding support, review and escalation while qualified client staff retain scientific and regulatory authority.
Pharma results: 99.96% MedDRA coding accuracy (Actigy BPO-reported)
- MedDRA coding accuracy rose to 99.96%.
- SAE case processing fell from 24.5 hours to 3 hours.
Results come from anonymized client engagements, are reported by Actigy BPO and are not independently audited. Results depend on scope. pharmacovigilance case study
What pharma and life sciences teams outsource
Common pharma and life-sciences workflows include:
Documentation & data entry
Transcription
QA & verification
AI data operations
At a glance
Pharma and life sciences: at a glance
| Provider | Actigy BPO (Prague; delivery in Bulgaria, Romania, Poland and Ukraine) |
|---|---|
| Industry | Pharmaceuticals & Life Sciences |
| Managed workflows | Documentation & data entry, Transcription, QA & verification, AI data operations, Finance back office, Customer & HCP support |
| Pricing model | Monthly FTE quote based on role, review requirements, hours and volume |
| Engagement | Managed team or staff augmentation |
| Team includes | Operators, supervision and QA defined against the sponsor's scope |
| Coverage | Up to 24/7, set per engagement |
| Delivery region | Bulgaria, Romania, Poland and Ukraine (Central and Eastern Europe) |
| Controls | Client-approved access, traceable records and documented review steps |
| Time to pilot | Agreed after access, training and quality-system review |
| You keep | Policy, approvals, and final decisions |
How does outsourced support fit life-sciences operations?
Actigy BPO, a nearshore BPO company based in Prague, gives pharma and life-sciences teams trained operators for accuracy-critical, document-heavy work. The team runs data entry, documentation, transcription, quality checks and back-office finance inside your systems. Map each workflow to the client's required access, review, records and escalation controls before work starts.
Accuracy and traceability are treated as core requirements. Work follows documented SOPs with maker-checker QA and complete records. Regulated, scientific, and quality-of-record responsibilities stay with your qualified staff. The delivery team supplies disciplined operational capacity for the surrounding execution.
In the published pharmacovigilance case study, the team ran the case pipeline up to medical sign-off. The work covered individual case safety report (ICSR) intake and triage, and Medical Dictionary for Regulatory Activities (MedDRA) and WHO-Drug coding. It also covered case narratives and submission-ready document assembly. That team worked from Poland, and its specialists held advanced nursing, pharmacy or bioinformatics degrees. The client kept development strategy, clinical protocols, causal conclusions and health-agency communications.
Capabilities
Which pharma and life sciences workflows can move to a managed team?
The operations team runs the six pharma and life sciences workflows below, from documentation and data entry to customer and healthcare professional (HCP) support. Each workflow follows documented procedures with QA and audit-ready records. Your team keeps policy, risk and final decisions. Each card below links to the service page for that workflow.
Documentation & data entry Accurate entry and management of structured documentation and records.
Transcription Dictation and document transcription with QA and template adherence.
QA & verification Quality checks and verification of documents and datasets to your standards.
AI data operations Labeling, dataset QA, and human-in-the-loop review for data and AI teams.
Finance back office Accounts payable, accounting, and reconciliation support.
Customer & HCP support Support and inquiry handling to documented scripts and standards.
Which life-sciences teams use managed support?
Manufacturers, life-sciences companies and data teams can assess a defined back-office queue against their accuracy and documentation requirements. Buyer types to consider include:
- Pharmaceutical manufacturers and distributors
- Life-sciences, biotech, and medical-device companies
- Data and documentation teams with high accuracy requirements
- Operations leaders standardizing document-heavy workflows
- Finance teams needing controlled back-office capacity
When does managed life-sciences support fit?
When the model is a strong fit
- Your workflows are accuracy-critical and document-heavy
- You need documented controls, QA, and audit-ready records
- Volume exceeds in-house capacity for data and documentation work
- You want to keep regulatory accountability in-house and offload execution
- You need consistent, repeatable process delivery
When the model may not fit
- You need regulated activities that require qualified persons of record to perform them directly
- You are buying a validated software system rather than an operations team
- You cannot share SOPs, templates, or quality standards
Delivery controls
What do pharma and life sciences teams gain from a managed operations team?
The delivery model combines traceable work, built-in verification and trained operators. These traits protect data integrity on regulated work. Four traits matter most:
Verification built in
Quality checks and verification steps protect document and data integrity.
Trained operators
Operators train on approved SOPs and complete the client's readiness checks before live work.
Cost-to-quality ratio
Efficient delivery that funds controls and QA, not the lowest possible rate.
Delivery method
How does a new pharma operations team go live?
The seven stages below help define and test a pharma operations scope. Controls follow your SOPs and quality standards. The team scales only after the pilot meets the agreed thresholds.
- 01
Process audit
The team maps the current workflow, volumes, systems, exceptions and quality bar, so scope and staffing rest on evidence.
- 02
SOP & KPI design
The team writes the standard operating procedures (SOPs) and agrees the key performance indicators (KPIs) and service levels before live work starts.
- 03
Team selection
The team selects operators and team leads who match your domain and your tools.
- 04
Training & knowledge transfer
Structured onboarding covers your SOPs, edge cases and systems. Each operator gets sign-off before the team carries production volume.
- 05
Pilot
A controlled pilot tests quality, throughput and turnaround against the agreed KPIs. The team tunes the process before scaling.
- 06
Scale
The team ramps to full volume with capacity planning, coverage models and the reporting cadence agreed up front.
- 07
Continuous improvement
Review sampled errors, record completeness and turnaround before approving changes to a controlled life-sciences workflow.
Related services and industries
Services
Industries
Resources
Visibility
What should monthly life-sciences reporting cover?
Actigy BPO reports the numbers that matter for life-sciences operations and reviews them with you on a fixed cadence. Outsourced work should make quality more visible, not less. The same reporting model runs for healthcare and clinic operations. Each report covers:
- A QA sample of completed work, scored against the accuracy bar agreed at go-live
- SLA attainment - turnaround and throughput measured against your targets
- Volume, backlog, and exception trends, so capacity stays ahead of demand
- Root-cause notes on any error, with the SOP change made to prevent a repeat
- A monthly business review with your point of contact and the team lead
Engagement model
How is pharma and life-sciences support priced?
Actigy BPO prices life-sciences operations per full-time equivalent (FTE) by role, based on scope, volume and complexity. The model follows the cost-to-quality ratio with the review, validation support, hours and exclusions stated in the proposal. Consider scoping transcription and document verification together, with a named lead and separate acceptance checks. The written scope lists the roles, quality thresholds and cost before the pilot starts.
First queue
Which pharma queue should move to an outsourced team first?
Actigy BPO recommends a first queue with clear rules, steady volume and a documented quality standard. Candidates include document control, data entry, transcription or a defined pharmacovigilance intake step. Strict deadlines alone do not make safety-case work a suitable first pilot; the qualified client owner must approve its risk, review and escalation requirements. Each of these queues has a written procedure, a measurable accuracy bar and a clear owner for regulated decisions.
Your qualified staff keep regulated, scientific and quality-of-record decisions. The team works inside your systems, follows your SOPs and escalates any case outside them. A paid pilot on one queue tests accuracy, turnaround and escalation before the scope grows.
Good pilot cases include a complete record, a missing field, a duplicate case, an unclear source document and a case that needs a qualified reviewer. The pilot scores accuracy, speed, escalation and whether each operator stopped at the authority boundary.
FAQ
Frequently asked questions
Which pharma and life-sciences workflows can be outsourced?
Actigy BPO handles documentation and data entry, transcription, QA and verification, AI data operations, finance back office, and customer or HCP support. These accuracy-critical, document-heavy workflows run with controls and audit-ready records inside your systems. Each workflow follows a written SOP with maker-checker QA.
How is work kept accurate and traceable?
Define the SOPs, maker-checker QA, verification steps and required records for each proposed workflow. Operators complete agreed training and readiness checks before live work. Review recurring issues and measure whether approved process changes improve quality. In the pharmacovigilance case study, a three-tier check combined safety rules, peer review and medical quality auditor review under sponsor-approved procedures.
Who retains regulatory accountability?
The client retains that accountability. The delivery team provides disciplined operational capacity for the surrounding execution, with the controls and documentation the sector expects. Regulated, scientific and quality-of-record responsibilities stay with your qualified staff. Medical signal discovery and direct health-agency communications also stay with you.
Can the operations team support life-sciences data and AI work?
Yes. The data team provides AI data operations to your guidelines: labeling, dataset QA and human-in-the-loop review. This supports data and AI initiatives, while your scientific team keeps research ownership. Your guidelines and quality thresholds define the work.
What to confirm before a pilot
Use these six questions to scope the engagement. Here are the short answers.
Start with a paid pilot
A pharma pilot tests accuracy, traceability and escalation on the approved sample before a larger scope moves.
Staffing-based pricing
The pharma quote lists roles and cost per FTE. Capacity changes depend on training, access and agreed review coverage.
You own the documentation
SOPs and process knowledge stay yours, so switching costs stay low.
Clean exit
If you end the engagement, the delivery team returns current documentation and supports the handover.
Data protection
Confirm the proposed life-sciences data safeguards and quality records. ISO 9001-aligned and SOC 2-aligned; not certified or audited.
Time zones
Agree processing hours, safety-case escalation and qualified-reviewer availability. Any 24/7 scope requires an explicit coverage plan.
Outsource the process. Keep control of the outcome.
Tell us what process you want to outsource. The scoping team will assess scope, complexity, staffing model, and delivery cost.
Describe your workflow, volume and required coverage. You decide on a pilot after reviewing the written scope.