CLINICAL RESEARCH & GENERIC DEVELOPMENT

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IN CLINICAL RESEARCH, A PROMISE OF PRECISION:

Maven is a metric-driven clinical research business with a global footprint and a stellar reputation that spans the globe.

Maven Clinicals, a privately held full-service CRO based in Hyderabad, India, is a highly efficient, metric-driven clinical research organization with a global reach. Maven Clinicals recognizes the value of high-quality clinical research services, and our highly skilled team works hard to give them to our sponsors at a reduced cost. We offer personalized solutions to fit sponsor study requirements as a vertically integrated CRO.

Services we provide:

  • Bioavailability | Bioequivalence Studies:

At maven, we share your enthusiasm for medical progress and recognize the importance of creative solutions in shortening your product’s time to market.

Our employees are known for their exceptional team chemistry and commitment to customer service.

We specialize in offering safe and ethical research solutions for Bioequivalence – Bioavailability studies as the leading provider of Clinical Pharmacology Services.

Our extensive experience conducting a wide range of bioavailability/bioequivalence clinical studies has provided us with a thorough grasp of the generic development process, giving our sponsors confidence that the outsourced project will be handled professionally and in the most cost-effective manner feasible. Our extensive infrastructure ensures that your project may be accommodated quickly for male/female or unique populations.

Our facilities undertake pharmacokinetic, bioavailability, and bioequivalence studies in strict accordance with national and international regulatory norms, which are overseen by an independent quality assurance team. Our employees can respond swiftly to a client’s request and act without needing to contact a committee because we have fewer levels of management. Our team members take ownership of the project, giving clients a more tailored, strategic approach to clinical management, based on the study’s phase, location, and goals.

We provide specialist services in the following sorts of investigations at Maven Clinicals:

  • Fasting and a well-fed state.
  • In healthy subjects, single and multiple doses were used.
  • Drug-drug interactions and drug-food interactions are both possible.
  • Administration can be accomplished in several ways.
  • Patient Population ( Pharmacodynamic and Pharmacokinetic studies) studies are unique.

Among the formulations in which we have experience include, but are not limited to:

  • Oral Formulations in Solid Form Tablets, capsules, soft gels, sprinkles, extended-release, immediate release, DR, and sustained release are all examples of dosage forms.
  • The formulation can be taken orally.
  • Formulations in liquid form Suspensions and syrups are two types of suspensions.
  • Parenteral nutrition Intramuscular, Intravenous, and Subcutaneous are the three types of injections.
  • The gel is applied to the skin.
  • Nasal and oral sprays
  • Dry Powder Inhaler, Metered Dose Inhaler
  • Patches on the skin.
  • Skin Bleaching Research
  • Phase II-IV

Our combined capabilities can help you reduce risk, ensure trial feasibility, and assure your program’s regulatory and commercial success.

Our clinical research experts are skilled at developing protocols, conducting studies, writing clinical study reports, and submitting regulatory documents. More than 200 clinical investigators across 110 research sites are working with our well-trained and highly qualified Project Managers, Senior Clinical Research Associates, Clinical Research Associates, and Clinical Trial Assistants who have years of clinical monitoring experience across various therapeutic areas.

Maven Clinicals provides a comprehensive variety of clinical research services to the pharmaceutical, medical device, biopharmaceutical, and contract research organization (CRO) industries, including:

  • Study Development
  • Site Qualification visit
  • Site Initiation visit
  • Interim monitoring visit
  • Site Closeout visit
  • Intellectual Advisory Board
  • Translational Science Specialists
  • Protocol Development
  • CRF Design & Distribution
  • Patient Recruitment

Furthermore, we have a track record of conducting New Drug Application (NDA) and Biologics License Application (BLA) clinical studies across a wide range of therapeutic areas for a variety of research types with a diversified group of healthy volunteers and patients.

  • PK(Pharmacokinetic) | Biostatistics & Programming

Maven’s  Pharmacokinetic | Biostatistics Team is knowledgeable and capable of providing appropriate statistical analysis for BA | BE studies as well as Phase II-IV clinical trials.

Our team of experts brings insight to trial design, creates complicated statistical analysis strategies, and assists customers with the regulatory filing procedure.

Protocol writing, statistical analysis, and report writing are all part of Maven Clinicals’ biometrics services. Our Biometrics Division has the most up-to-date software, such as Win NonLin and SAS (SDMS & MED X view).

Our biostatistics staff can handle changes in Sponsor requirements and responds quickly, aiming for complete satisfaction with the highest quality of service.

Our services include:

Database Programming

  • CRF Design (paper & electronic).
  • Annotation in the CRF format.
  • Database programming is a type of programming that is used to create databases.
  • Checks for Validation

Data Management

  • Data Acquisition.
  • Reconciliation of data.
  • Management of Discrepancies.
  • Coding in the Medical Field (MeDRA & WHODD).
  • Locked database.
  • Extraction of data for reporting.

Biostatistics

  • Randomization.
  • Estimation of the sample size
  • Inputs for Trial Design
  • Plan for Statistical Analysis
  • Analytical Statistics
  • Subject Matter Expert in Biostatistics (Tie-up with global consultants).

Statistical Reporting 

  • TLF Programming 
  • Data Mapping at CDISC (SDTM & ADaM).
  • Repository of Clinical Data
  • Analyzing and reporting on a pooled set of data.
  • Reporting of Adverse Drug Reactions (ADRs).
  • Data Cleaning Reporting & Patient Profiles
  • Analyze the feasibility.
  • CDISC | SDTM | ADaM standards | SAP & TLG|F mock shell preparation
  • Blinded envelopes are being uploaded for EDC.
  • Calculations for Pharmacodynamic and Pharmacokinetic studies are being worked on.
  • Analyze and report on statistical data.
  • Review the preliminary results.
  • Respond to regulatory inquiries as soon as possible.
  • Keep current with the latest statistical methodologies approved by regulatory agencies such as the USFDA, EMEA, and DCGI.
  • Medical Writing

Medical writing in the context of clinical research is undeniably important in determining whether novel substances succeed or fail.

Maven Clinicals’ medical writing domain is well-equipped with professionals who have strong academic backgrounds as well as valuable scientific experience in a variety of therapeutic areas; They help compile, organize, write, edit, and produce a variety of medical and scientific documentation that is needed to support product development operations.

Our clients may rely on our writers at each level of the product development process, from clinical development plans and investigator brochures to regulatory submissions and licensable applications.

We can work on study reports, patient narratives, DSMB updates, labeling, or other documents containing study data because we have in-house experience ranging from Pharmacodynamic and Pharmacokinetic studies to pharmacovigilance.

Clinical development plans are a specialty of Maven Clinicals’ Medical Writing service, which includes:

  • Abstracts, manuscripts, and journal articles are all available.
  • Brochures for investigators and annual updates
  • Forms of informed consent.
  • Protocols are the rules by which things are done.
  • Reports on clinical trials.
  • Common Technical Documents’ clinical sections (CTDs).
  • New Drug Applications have clinical sections (NDAs).
  • PSURs (Phase-by-Phase Update Reports) and other pharmacovigilance documents
  • Briefing material for the FDA conference.
  • Clinical hold orders are handled in a timely manner.
  • Reports on preclinical studies, expert reports, and summaries.
  • Manuals for the Data Safety Monitoring Board (DSMB).
  • Summaries in both written and tabular form.

Reporting on Bio-Analytical Results:

  • Reports on Method Validation.
  • Reports on IRS
  • Reports on bioanalytical
  • Documentation that is ready for submission (Hyperlinked eCTD formatting)
  • Dispatch and archival services.
  • Benefit | Aside from medical and scientific literature reviews, risk assessment reports are useful.
  • Our one-of-a-kind medical writing services comply with ICH guidelines and other regulatory standards.