Early Phase

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Centered on our 10 years of research excellence, Maven offers a wide variety of early phase services completed by our experienced experts. These programmes are available as part of an integrated programme or as a stand-alone service at our clinical and multicentric locations.

Professionalism Clinical trials of different types:

  • Doses, both single and multiple
  • Parallel, Crossover, Partial Replicate, and Full Replicate are the four types of replication
  • Fasting, Feeding, and Applesauce
  • Long-term accommodation (confinement up to continuous 17 days)
  • Studies that necessitate regular blood screening, a 45-day washout period, and constant monitoring.
  • People with Disabilities
  • Dosing for 5 to 7 days in a row in multiple dose studies
  • Be ready to set up a hospital
  • Setup of a hospital BE study
  • Proof-of-Concept research

Various Administration Routes (dosage forms)

  • injectables (IM, IV, Subcutaneous)
  • Oral care (Tablets: IR,ER,SR,MR,CR,DR,ODT,Chewable)
  • Capsules (capsules): (ER, MR, DR, Soft Gelatin)
  • Granules for Suspension
  • Rectal Rectal Sublingual (Suppository & Foam)
  • Transdermal (transdermal) (Patch, Topical Cream, Topical Gel, Lotion)
  • genital vaginal (Tablet, Cream, Gel)
  • pulmonary fibrosis (MDI & Nasal Spray)

Achievements in BA/BE-Phase 1

  • (Adhesion/PK) 100+ derma/patch BE studies
  • The Open First to File analysis was completed successfully in multiple locations.
  • There are more than 70 studies of continuous cardiac monitoring (Ranolazine, Propafenone, Flecainide etc.)
  • 23 long housing studies (Citrate/Potassium Chloride)
  • For long washout, there are 88 studies (62 pivotal, 26 pilot) (Levothyroxine, Enzalutamide, Aripiprazole, Empagliflozin and Linagliptin, Brexpiprazole etc.)
  • 154 studies for hormonal preparation (Ethinyl Estradiol+Levonorgestrol, Desogestrel+ Ethinyl Estradiol, Levothyroxine, Methylprednisolone, Prednisolone, Hydrocortisone, Liothyronine, Drospirinone+Ethinyl Estradiol, Norethindrone Acetate +Ethinyl Estradiol, No
  • 45 research findings on the elderly population (Brexpiprazole and Aripiprazole)
  • A phase I, multiple-dose, placebo-controlled study was conducted to assess the safety and tolerability of a topical cream with a 15-day housing period.06 sublingual tablets studies (Nitroglycerin 0.6 mg) demanding frequent blood sampling
  • Biosimilars have been the subject of 12 studies (Darbepoetin, Enoxaparin, Pegfilgrastim, Repoitin, Adalimumab, Trastuzumab)
  • Extensive screening parameters, long accommodation, long washout, large sample size, and so on (Pegfilgrastim)
  • Octreotide depot injection was studied in two trials (one pilot and one pivotal) with a larger sample size (n=220) and 70-day ambulatory samples.

MEDICAL SERVICES INTEGRATED DEPARTMENTS

  1. Medical Review of the Clinical Trials Medical Review of the Clinical Trials

  • Study Teams and Sites are being trained.
  • Meetings of the SEC are held at DCGI.
  • On-the-spot tracking
  • Identifying and mitigating risks by central monitoring
  • Reports on feasibility studies and disease demographics from India and other countries
  • Informed consent documents Protocol Clinical research report
  • Journals on specific topics
  • Forms for case reports
  • Aids to patient care

  1. Regulatory services:

  • Clinical and nonclinical portions of the Popular Technical Document (PTD) 
  • Regulatory Writing Investigational Medical Product Dossier (IMPD) 
  • Investigator Brochure (IB) ( Common Technical Document )
  • Briefing packages for the IND, 505(b)(2), and pre-EMEA meeting
  • Monographs on Products
  • DCGI submission executive summary and SEC presentation
  • Synopses for the web (Clintrial.gov, EU clinical register, CTRI etc)

  1. Writing a Scientific Paper

    • Assistance with Publication
    • peer-reviewed research Publications (from preparation to submission to journals/congresses)
    • Conference coverage, abstracts, posters (content and layout), slide sets
    • Medico Marketing Assistance
    • Brand Lexicon Newsletters, Flsh cards, Detail Supports, Leave Behind Leaflets (LBLs),
    • Product Monographs/Drug Brochures
    • Compendiums/Booklets
    • Educational materials for patients
    • CME Presentations/Abstracts
    • Documents for Training
    • Modules for online learning and training
    • Materials for Patients

LABORATORY SERVICES

Maven combines scientific experience with cutting-edge technology and a dedication to high-quality service. Central lab research, bioanalytical, Pharmacokinetics (PK) facilities, Immunogenicity (ADA), Bio marker, and Vaccine Immunogenicity testing are all part of our comprehensive lab services. Services provided by the lab include:

    • Bioanalytical
    • IVRT 
    • Immuno Analytics 
    • Vaccine Research 
    • Biomarkers 
    • Cell Based Assays
    • Microbiology at the Central Lab

BIOANALYTICAL

Expertise & Capabilities in BIOANALYTICS:

  • Bioanalytical assays for unstable compounds, metabolite back conversion compounds, endogenous compounds, liposomal products, chiral compounds, and elemental analysis are among my specialties.
  • Dedicated teams to ensure that all work is carried out in accordance with standard operating procedures (SOPs) and all relevant regulatory guidelines
  • More than 600 validated assays that are compliant with international regulatory agencies. To see the list of assays, click here.
  • About 6 million samples have been examined.
  • A highly skilled team is involved in the MD and MV of easy to complex assays using the most sensitive LC-MS/MS technology.
  • Possess the ability to perform in-depth literature searches for difficult assays.
  • Analytical ability to investigate the effect of significant circulating metabolites on the assay process.
  • Experiments covering precision and accuracy, as well as the all-important stabilities tests, were used to establish meticulous process creation strategies.

 

Infrastructure

  • 38 LC/MS/MS (Liquid Chromatography/Mass Spectrome (API 4000, API 5500 & API 6500 equipped with UFLC & HPLCs)
  • a single ICP-OES (Thermo iCAP 6300 duo)
  • For dedicated method creation and validation, a separate LC-MS, team, and lab are set up.
  • Services for biorepository: Fridge More than 1.5 million samples can be stored at -20°C and -70°C. Thermometer

 

Inspection by the regulatory authorities:

Various regulatory bodies around the world have successfully reviewed or audited Maven. Our flawless regulatory track record is the product of our strict adherence to the relevant standard(s) and standards set out by the ICH, FDA, EMA, and other clinical and analytical bodies. Science and Integrity, two of our enshrined principles, serve as the basis for our preparation and execution. Our core principles of Science and Integrity serve as the basis for our preparation and execution, which is aided by a thorough understanding of the regulations.

IVRT

Maven Research provides scientific expertise with state-of-the-art technologies reinforced by commitment for quality delivery. Our comprehensive lab services include central lab testing, bioanalytical, Pharmacokinetics (PK) services, Immunogenicity (ADA), Bio marker, Vaccine Immunogenicity testing.

Expertise

Developed IVRT Methods:

  • Clobetasol propionate 0.05% cream
  • Clindamycin (1.2%) /Benzoyl peroxide (5%) Gel

Infrastructure:

  • Housed on an isolated 1,000 sq. ft. laboratory
  • Complement to the existing 11,000 sq. ft. GLP compliant Bioanalytical Lab Equipped with 2 Hanson Microette 6 cell Diffusion systems for conducting IVRT MD trials
  • Installed Hanson 2 Phoenix DB-6 Diffusion Cell System for conducting IVRT validation and sample analysis trials
  • Have capacity to house up to 6 IVRT Diffusion Cell Systems
  • Currently we have 2 Schimadzu LC-2040C 3D Plus HPLC systems with audit trial
  • Have capacity to house up to 6 HPLC systems Modern Sample Preparation Laboratory Centralized UPS with Back-up Generator

IVRT Methods Under Development:

  • Acyclovir cream
  • Acyclovir ointment
  • Dapsone cream

IMMUNOANALYTICS

Maven’s Large Molecules laboratory is committed to assisting clients in advancing their research initiatives by offering high-quality, precise biosimilar development outcomes. The pharmacokinetics and immunogenicity lab at Large Molecule has considerable expertise dealing with therapeutic monoclonal antibodies, recombinant proteins, and hormones to support worldwide clinical trials.

Services: 

  • ELISA, Clot-based assays, and Chemiluminescent microparticle-based assays for pharmacokinetic analysis of large molecule biologics or biosimilars method development/transfer 
  • Screening, confirmatory, titer, and NAB assays are all part of a multi-tiered immunogenicity assay.
  • Neutralizing antibody assays based on cells (CBA) and competitive ligand binding (CLB).
  • Validating methods in accordance with international rules, legislation, and best practises (GXP)
  • Sample preparation, storage, logistics, tracking, archival, and management are all tasks that must be completed.
  • Immunogenicity and PK data were statistically analysed.
  • Data archival, report authoring, and lab manuals.
  • Antibody labelling and crucial reagent life cycle management

Expertise:

  • In immunoassay development, validation, and large-scale sample analysis, all in accordance with regulatory criteria.
  • A wide variety of assay formats and instruments are available.
  • Project teams with experience in immunogenicity, PK/PD investigations, and pharmacokinetics.
  • Personnel who have been trained in GLP/GCLP.
  • Sample management, quality control, and quality assurance are all handled by separate teams.
  • Electronic records and signatures that comply with 21 CFR part 11 of the US Food and Drug Administration.

Maven UNIQUE CAPABILITIES

Colmtrack

  • Fully validated, 21 CFR compliant in-house developed and web based application

Salient features

  • Fully validated to meet 21 CFR Part 11 compliance
  • A complete web-based system for all of column management needs
  • Captures end to end information – procurement, reservation, washing, tracking and up to disposal
  • Real time tracking of columns ensuring no missing column
  • Get all the information – Certificate, column care, usage history, age, current location, reservation status accessible from any location any system
  • Analytics to help the user while ordering columns
  • First of its kind in the entire industry
  • Each action is audit trailed
  • Automatic ID and controlled label generation
  • Integrated library for Column washing & regeneration procedures
  • Intuitive washing time calculator with washing detail manager
  • Different menu options for column selection based on application MD, MV, study
  • With information/help section on each step to guide for end users and external auditors in accordance with house SOPs
  • User management and User rights distribution for System Access Control

IAM

Instrument activity manager (IAM) is a central system for tracking all the lab activities which are performed at regular frequency like Calibration, preventive maintenance, and related activities.

BIOMETRICS

Maven excels in biometrics, which is one of its centers of excellence. We have carved out a niche for ourselves over the course of more than 15 years of experience. Biometric team offers robust and cost-effective outsourcing solutions for Clinical Data Management, Biostatistics & Programming, and CDISC with over 100 qualified professionals.
  • Data Management is the management of data.
  • Programming and Biostatistics
  • CDISC is a non-profit organisation that helps people with disabilities

DATA MANAGEMENT

It is a term that refers to the management of data.

Expertise:

  • Complete clinical data management services for both eCRF and paper trials, including CRF design, database deployment, query generation, and database lock (DBL).
  • A solid IT infrastructure ensures the reliability, privacy, and availability of your data and services. Working with industry leading CDM systems has given me a lot of experience.
  • To comply with ICH standards, national regulations, and guidelines, efficient and tested processes with comprehensive documentation, including SOPs, working procedures, and study-specific documents, are required.
  • Highly qualified personnel with experience in Phase I-IV trials for a wide range of clinical fields, including biologics and biosimilars.
  • At various levels of reporting and data preparation, stringent quality protocols such as senior review (QC) and independent QA are implemented.
  • On-time delivery of high-quality data

Therapeutic Experience

  • Cardiac
  • Dermatology
  • Endocrine and Metabolism
  • Nervous system
  • Oncology
  • Respiratory
  • Vaccine
  • Gastroenterology
  • Haematology
  • Hepatobiliary
  • Immune system
  • Ophthalmic
  • Psychiatry
  • Rheumatology
  • Infections and infestations
  • Infectious diseases
  • Injury, poisoning and procedural complications
  • Musculoskeletal and connective tissue
  • Renal and urinary
  • Reproductive system and breast

Rich experience in every phase of Data Management

  • START-UP PHASE

    • Designing Case Report Forms (pCRF / eCRF).
    • Development of a Data Management Strategy.
    • Edit and double-check the requirements.
    • Plan for an External Data Agreement (e.g. Lab, ECG, Device data etc).
    • Project Management Data Management
    • Completion of the CRF is governed by the CRF Completion Guideline.
    • Specification for Database Design.
    • CRF with annotations (aCRF).
    • Designing a database
    • Database programming is a form of programming that is used to create databases.
    • Acceptance Testing by Users (UAT).
    • Database is currently active.

  • CONDUCT PHASE

    • Data collection and processing that complies with CDISC-CDASH / SDTM
    • In EDC research, electronic data capture is used.
    • In paper research, there is double data entry.
    • Management of Discrepancies (System/Manual) Self-Evident Corrections
    • Tracking & Closing Queries
    • SAE data reconciliation
    • External data reconciliation and cleaning e.g. Lab, Device Data etc.
    • SAS system-based data review
    • Lab normal management
    • Medical Coding using MedDRA and WHO Drug Global
    • Data Export and Transfer
    • Standard report for project management
    • Ad-Hoc report

  • CLOSE-OUT PHASE

    • Database quality audit
    • Independent review for each document
    • Quality Control on all data processing steps
    • Quality Assurance
    • Database soft lock/ hard Lock/ Interim lock

    BIOSTATISTICS AND PROGRAMMING

    Services:

    • BE and Clinical trial research design, as well as statistical inputs, are included in the protocol.
    • nQuery/Pass/SAS – tools for determining sample size
    • The process of creating randomization schedules.
    • Mock-shells for the Statistical Analysis Plan (SAP).
    • Sponsor-specific criteria for data submission in CDISC format.
    • SAS software was used to develop and validate the TFL.

    BA-BE / Phase 1

    • Pharmacokinetics and pharmacodynamics are two terms that are used interchangeably. 
    • Studies on bioequivalence.
    • Studies on SAD and Crazy.
    • Topical dermatologic corticosteroids have been studied for vasoconstriction and dose response (DRC).
    • Bioequivalence of populations in vitro (PBE).
    • Analysis of adhesion, irritation, and sensitization (HRIPT).
    • Carcinogenicity studies statistical analysis.
    • Bootstrap analysis is a statistical method for determining the probability 
    • Analysis of the cut point, sensitivity, and specificity.
    • Data on equilibrium and kinetic binding.

    Phase II- IV

      • Phase I-IV tests, patient registry trials, Post-Marketing Surveillance studies, and Claim studies all require strong statistical expertise.
      • Statistical insight into study design and primary endpoint selection (s)
      • Oncology, dermatology, immunotherapy, cardiology, diabetes, psychiatry, and ophthalmology are some of the clinical areas.
      • SOPs, checklists, and documentation-driven processes are all well-defined.
      • SAS programmers and biostatisticians on a tea

Consumer Research

Biostatical tools

  • Phoenix® WinNonlin®
  • SAS®
  • PASS (Power Analysis & Sample Size)
  • nQuery
  • CDISC Services

CDM tools

Data management team have experience of working on various CDM tools CodeAngelo ® – Cliantha’s Proprietary Tool and many more

CodeAngelo ®

Cliantha’s proprietary Clinical Data Management platform: CodeAngeloTM – 21 CFR part 11 compliant system

  • Diversified Features
  • Instant Validation
  • Role based secure access
  • Dynamic data entry & review workflow
  • Mid study changes Manage amendments and any mid study change instantly.
  • Standard, Ad-Hoc Reports & Role based Dashboard
  • Integrated Query Management
  • Medical coding Interface – Auto & Manual with MedDRA, WHODrug Global
  • Rapid CRF design
  • Local lab management Effectively manage local and normal lab ranges
  • Complete Reporting More than 30 reports are available along with ad-hoc query-based report.
  • Differentiating Primers
  • Advanced Performance Reporting, and Analytics for Senior Management

Flexible licensing and SAAS (Software as a Service)

Intensive Backup Solution Highest Level of Security, Reliability & Scalability

REGULATORY AFFAIRS SERVICES:

  • Pre-IND packages
  • IND submission preparation
  • ITA submission
  • Client support for medical device license application for Health Canada