TrialSite PartnersClinical Site Management

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Services

Site services for every stage of your study

Take a single service or the full package. Each engagement starts with a clear scope, named owners and agreed timelines.

SERVICE 01

Site identification & feasibility

We match your protocol to investigators with the right patient population, infrastructure and research experience.

  • Investigator and site shortlisting by indication and region
  • Patient-flow and competing-trial review
  • Infrastructure checks: storage, equipment, lab, pharmacy
  • Feasibility questionnaires completed and verified
  • Written feasibility report with enrolment estimates

SERVICE 02

Investigator & site onboarding

We prepare sites to be ready on day one of activation.

  • CDA, budget and clinical trial agreement coordination
  • Investigator CVs, GCP certificates and delegation logs
  • Site staff protocol and GCP training records
  • Investigator Site File (ISF) set-up
  • Site initiation visit readiness

SERVICE 03

Ethics committee & regulatory submission support

We prepare and track site-level submissions so approvals are not the bottleneck.

  • EC dossier preparation and submission tracking
  • Support with registered EC requirements under NDCT Rules 2019
  • CTRI registration support for the sponsor or CRO
  • Amendments, safety reports and periodic progress reports to EC
  • Informed consent documents, including translations and audio-visual consent where required

SERVICE 04

Patient recruitment & retention

Recruitment plans built around how patients actually reach each site.

  • Site-specific recruitment and pre-screening plans
  • Screening and enrolment logs
  • Informed consent process support for investigators
  • Visit scheduling, reminders and travel coordination
  • Retention follow-up and missed-visit recovery

SERVICE 05

Clinical research coordinator staffing

Trained coordinators, placed where you need them.

  • Full-time dedicated or shared CRC models
  • Protocol-specific training before deployment
  • Back-up cover for leave and peak workload
  • Supervision by our site lead with regular performance review

SERVICE 06

Source documentation

Records that meet ALCOA+ expectations and stand up to verification.

  • Source document templates aligned to the protocol
  • Contemporaneous, attributable visit documentation
  • Certified copy processes for electronic records
  • Regular internal QC of source and ISF

SERVICE 07

Data entry & query resolution

Clean data, entered on time.

  • EDC entry against agreed timelines after each visit
  • Query resolution with investigator sign-off
  • Discrepancy tracking and trend reporting
  • Support for database lock activities

SERVICE 08

Investigational product management & pharmacy supportPharmD strength

Our pharmacist-led strength: careful control of every unit of investigational product.

  • IP receipt, storage and temperature monitoring logs
  • Excursion handling per sponsor instructions
  • Dispensing support, accountability and returns
  • Randomisation and IWRS/IXRS system support
  • Concomitant medication review and drug interaction flags for the investigator

SERVICE 09

Monitoring visit support

Productive monitoring visits, with action items closed fast.

  • Visit preparation: source, ISF and EDC ready for SDV
  • Remote monitoring document access where permitted
  • Action-item tracking and closure
  • Audit and inspection readiness support

SERVICE 10

Site close-out

A clean finish that protects your data.

  • Final IP reconciliation and return or destruction
  • Outstanding query and document closure
  • ISF completeness check and archiving
  • Final notifications to the ethics committee
Start a conversation

Planning a study in India?

Share your protocol synopsis and target indication. We will come back with a site feasibility view within five working days.

Request feasibility