Emerging biotechnology and pharmaceutical developers
Programmes that need a clear UK route before specialist work is commissioned.
Clinical Research & CRO Support
Clinical development, connected to evidence and accountability.
NovaPharm coordinates UK-focused development programmes by aligning regulatory pathways, quality governance and qualified specialist delivery, with responsibilities visible from the start.
Conceptual programme-governance visual; not NovaPharm personnel, premises or a live clinical programme.
SupportsEmerging, specialty and international developers
CoordinatesUK pathway, quality and specialist interfaces
SeparatesNovaPharm, specialist and sponsor duties
ConnectsDevelopment evidence to later market decisions
Scope stated plainly
NovaPharm provides scoped programme coordination. It is not represented as a sponsor or full-service CRO. Specialist functions require appropriately qualified providers; sponsor duties and authority decisions remain with their accountable owners.
Sponsor context
Complexity grows at the interfaces.
NovaPharm makes the programme question, responsibility boundaries and evidence route visible before specialist work is commissioned.
Specialty-pharma and product owners
Assets with connected scientific, quality, supply and market decisions.
International development organisations
Teams seeking UK pathway context and an explicit responsibility model.
Sponsors using specialist providers
Programmes that need coherent evidence, decisions and escalation across vendors.
Transparent Delivery Architecture
Three responsibility lanes. One visible programme.
Delivery starts with clarity about who coordinates, who performs specialist work and what the sponsor retains.
Delegation allocates activities. It does not erase sponsor oversight or applicable legal and regulatory duties.
NovaPharm-led
Programme architecture and governed coordination within an agreed scope.
- Evidence assessment
- Responsibility mapping
- UK pathway coordination
- Development continuity
Qualified specialist delivery
Functions requiring proven infrastructure or professional accountability.
- Clinical operations
- Data and biometrics
- Medical and safety oversight
- Laboratories and specialist writing
Sponsor-retained
Duties that remain with the sponsor when activities are delegated.
- Sponsor designation and duties
- Provider oversight
- Protocol and risk decisions
- Safety and compliance accountability
Shared line of sightScopeDecisionEvidenceEscalation
Clinical Development Navigator
Stage 1 of 8: Development strategyEight stages. Responsibilities and evidence visible at every gate.
Select a stage to orient the programme. Every stage remains available without JavaScript.
- 01NovaPharm-led framing
Development strategy
Define the asset question, evidence gap and decision the programme must enable.
- 02Coordinated input
Feasibility and planning
Map specialist functions, supply dependencies, assumptions and decision gates.
- 03NovaPharm-led coordination
Regulatory and ethics preparation
Coordinate the UK pathway and evidence package with qualified specialists.
- 04Specialist delivery
Study start-up
Set provider interfaces, records, escalation and readiness before activation.
- 05Sponsor oversight supported
Study conduct and oversight
Keep milestones, issues and provider decisions visible to the sponsor.
- 06Qualified specialist delivery
Data, safety and documentation
Connect specialist work to controlled, attributable records.
- 07Coordinated close-out
Close-out and reporting
Reconcile decisions, essential records and unresolved actions.
- 08NovaPharm-led continuity
Regulatory and market continuity
Carry verified evidence into the next regulatory or market decision.
Service architecture
Commission the right work, with the right boundary.
Eight modules connect programme need to an explicit evidence output. Expand a module for the full scope.
01NovaPharm-ledClinical-development strategy and programme planning
Programme needA programme can commission activity before its critical decisions, evidence gaps and UK route are explicit.
NovaPharm approachNovaPharm structures the development question, dependencies, decision gates and required specialist inputs with the sponsor.
Defined outputA programme brief, responsibility map and staged delivery architecture suitable for provider selection and governance.
Discuss programme strategy02Coordinated specialist inputUK regulatory and ethics pathway coordination
Programme needMHRA, Research Ethics Committee and operational preparation can become disconnected or sequenced incorrectly.
NovaPharm approachCoordinate requirements, submission dependencies and evidence ownership with qualified regulatory contributors and the sponsor.
Defined outputA visible UK pathway plan; authorisation and favourable ethics opinion remain decisions of the relevant authorities.
Discuss UK pathway planning03NovaPharm-ledClinical project and specialist-vendor architecture
Programme needMultiple providers create gaps when interfaces, decisions and escalation routes are not designed before delivery.
NovaPharm approachMap accountable roles, delegated activities, dependencies, governance forums, milestones and exception routes.
Defined outputA transparent delivery model that preserves sponsor visibility across appointed providers.
Map a delivery model04NovaPharm-led with specialist supportStudy documentation and evidence governance
Programme needImportant records lose context when document ownership, versioning, decisions and quality checks are fragmented.
NovaPharm approachDesign controlled document structures, review states, decision records and inspection-readiness checkpoints; specialist TMF services are qualified separately.
Defined outputA governed evidence architecture aligned to the agreed programme and provider model.
Review document governance05NovaPharm-led planningQuality-by-design and risk-proportionate oversight planning
Programme needQuality activity can become retrospective when critical-to-quality factors and oversight evidence are not defined early.
NovaPharm approachSupport responsibility definition, risk framing, issue escalation, CAPA awareness and oversight records without transferring sponsor accountability.
Defined outputA proportionate governance plan focused on material risks, data integrity and patient-safety boundaries.
Discuss quality oversight06Qualified specialist deliveryData, biometrics and safety-function coordination
Programme needSpecialist data and safety functions can operate as separate workstreams without a shared decision context.
NovaPharm approachDefine interfaces, inputs, outputs, timelines and escalation expectations before appointing appropriately qualified providers.
Defined outputCoherent specialist work packages with explicit sponsor and provider responsibilities.
Scope specialist functions07Planning and specialist orchestrationClinical-supply and IMP logistics coordination
Programme needProduct, packaging, release, storage and distribution dependencies can threaten start-up or continuity when addressed late.
NovaPharm approachMap supply assumptions and coordinate qualified manufacturers, release professionals and logistics providers within the authorised programme.
Defined outputA clinical-supply responsibility and evidence plan; NovaPharm does not claim owned manufacturing, depots or current IMP distribution.
Discuss clinical-supply planning08NovaPharm-ledPost-study regulatory and market-access continuity
Programme needDevelopment evidence, supply design and commercial pathway decisions are often reconsidered too late or without their original context.
NovaPharm approachConnect programme outputs to the next verified regulatory, quality, product and market-access decision.
Defined outputA controlled transition brief that preserves evidence lineage and unresolved dependencies.
Plan development continuitySponsor Decision Framework
Choose the right delivery architecture.
Some programmes need a conventional global CRO. Others benefit from focused coordination, transparent specialist delivery and direct senior oversight.
Quality and governance
Evidence should move with every accountable decision.
The model connects responsibility, records, risk and escalation. It does not replace programme-specific legal, medical or regulatory advice.
Controlled programme recordDecision context preserved
01ResponsibilityAccountable owner
02EvidenceVersion and source
03RiskMaterial signal
04EscalationDecision and action
Defined responsibility
Every material activity has an accountable owner and visible interface.
Quality by design
Critical-to-quality factors are considered before avoidable complexity is embedded.
Risk-proportionate oversight
Attention and evidence are directed to material programme and participant risks.
Controlled records
Decisions, versions, issues and actions remain attributable and reviewable.
Patient-safety boundary
Medical and safety decisions remain with appropriately qualified and authorised people.
Applicable UK approvals and sponsor responsibilities must be established for the actual programme. NovaPharm does not guarantee authorisation, ethics opinion, recruitment, timing or outcome.
Explore UK pathway supportEngagement path
From discussion to a defined route.
- 01
Initial discussion
Define the programme question, stage and intended decision without requesting patient-identifiable information.
- 02
Evidence and need assessment
Review non-confidential evidence, assumptions, dependencies and gaps.
- 03
Responsibility mapping
Separate sponsor, NovaPharm and specialist-provider duties before scope is agreed.
- 04
Proposed engagement route
Set the suitable work packages, evidence outputs and governance route without guaranteeing acceptance or timing.
Scientific and digital continuity
Judgement stays human. Programme evidence stays connected.
Strategic focus areas and the technology architecture inform scoped conversations; neither is presented as completed NovaPharm trial delivery or a live sponsor workspace.
Oncology
Strategic scientific and portfolio focus; not a claim of completed NovaPharm clinical trials.
Specialty medicines
Programme and product focus where evidence, supply and governance dependencies require closer integration.
Oral-liquid formulations
Formulation and technology-transfer interest supported by senior scientific input.
Selected complex or hard-to-source products
Partner-development priority subject to product, rights, regulatory and supply evidence.
Programme record
A structured view of scope, responsibilities, milestones and verified status.
Controlled documents
Document relationships, versions, review states and access boundaries.
Decision and issue trail
Attributable decisions, actions, exceptions and escalation history.
Role-based visibility
Access architecture is implemented in NovaPharm's platform; a live sponsor workspace is not claimed.
Senior judgement
Scientific scrutiny and accountable programme framing.
Verified NovaPharm leadership connects corporate direction, scientific review and controlled UK pathway decisions without inventing trial history.
Chief Executive Officer
Vishal Chakravarty
Leads strategic direction, UK market entry, regulatory pathway coordination and board governance.
View verified profile
Director & Chief Scientific Officer
Dr Girish Shantilal Achliya
Supports scientific strategy, product development and technical due diligence.
View verified profileDevelopment-to-Market Continuity
Carry the evidence forward instead of rebuilding the story.
Development outputs remain connected to the regulatory, product, quality, supply and market decisions that follow.
Every transition remains conditional on verified evidence and applicable permission.
Development question
What must be decided?
Controlled evidence
Which records support it?
Regulatory decision
Which pathway applies?
Product and supply design
Can continuity be governed?
Market readiness
Proceed only when authorised.
Related evidence
Quality, traceability and regulated-operation perspectives.
Adjacent context, not clinical-trial case studies or regulatory advice.
Clinical-development FAQs
Six clear answers before a programme conversation.
What clinical-development support does NovaPharm provide?
NovaPharm's current public offer is centred on programme framing, UK pathway coordination, responsibility mapping, document and decision governance, specialist-vendor coordination, clinical-supply planning and development-to-market continuity.
Is NovaPharm a full-service CRO?
No. NovaPharm does not present itself as a global full-service CRO, investigator-site network, clinical-trial sponsor or in-house biometrics organisation. Functions outside its evidenced scope require appropriately qualified specialists.
Can NovaPharm coordinate specialist CRO functions?
Potentially, following programme assessment and capability mapping. Any specialist provider must be appropriately qualified, contracted and governed for the agreed function.
Does NovaPharm support UK regulatory and ethics preparation?
NovaPharm can coordinate pathway planning and evidence responsibilities with qualified regulatory contributors. MHRA authorisation and a favourable Research Ethics Committee opinion are decisions of the relevant authorities.
Can NovaPharm support clinical-supply coordination?
NovaPharm can help map clinical-supply responsibilities and coordinate qualified parties. It does not claim owned manufacturing, clinical depots or an operational IMP distribution network.
How do we begin a discussion?
Use the clinical-development enquiry route to share high-level, non-confidential programme context. Do not submit patient-identifiable data, adverse-event information or urgent medical information through the form.
Official sources used for the UK responsibility and governance framework
- MHRA: Clinical trials for medicines, apply for approval in the UK
- MHRA: Clinical trials for medicines, roles and responsibilities
- MHRA: Guidance on quality and risk proportionality
- MHRA: Compliance with ICH E6 GCP in the United Kingdom
- Health Research Authority: Combined Review
- Health Research Authority: Research roles and responsibilities
- ICH E6(R3) Good Clinical Practice
Reviewed 18 July 2026. Programme-specific requirements must be confirmed against current official guidance and professional advice.
Clinical-development enquiry
Bring the programme question. Start with the responsibility map.
A web enquiry does not confirm acceptance, scope, confidentiality arrangements, timing or a proposal. Share only high-level, non-confidential business information. Do not submit patient data, adverse-event information or urgent medical information.