Bio fact is a Site Management Organization (SMO).
We have our experienced, qualified & dedicated research team to contribute, to accelerate & strengthen Clinical Research.
Our committed staff enables us to accomplish clinical research projects within time while maintaining high quality & ethics.
Our Core Values
We understand the need of our customer/sponsor. Hence, we are committed to long-term partnerships by timely delivering on our commitments with quality that enhance trust and integrity of our services.
Quality Policy
Bio fact research Pvt. Ltd. is committed to achieving customer satisfaction by providing quality regulatory compliant research and developmental services to the Indigenous and global health care market players in compliance with internationally recognized regulatory standards and guidelines through stringent quality management system, robust regulatory frame work and effective implementation of GXP practices.
Our Mission
To be an integral part of clinical research and developmental cycle, through which a Safe and effective medicine for human use is developed in compliance with internationally recognized regulatory standards and guidelines.
Our Vision
To be a first referral Site Management Organization to render One Stop Solution for Clinical Trial Services in compliance with global regulatory requirements to the clientele across the globe.
Our Strengths
- Biofact project management team has members from each of the function department to ensure the project will meet the CRO/SPONSOR requirements.
- Our experience, qualified, dedicated staff.
- Distinguished investigators, Network throughout India.
- High performance, uncompromising compliance, ethics & quality data.
- Participated in every phase of clinical trail & every therapeutic area.
- Our patient recruitment & retention system.
- Cost effective without compromising quality.
- Quality, Ethics, Confidentiality, are our core values.
- To deliver projects, our team work through meticulous planning & CO-ordination with a clear focus on providing quality, ethical compliance, timeline management.
- Our managers team provide leadership and guidance to built a project team a top-notch.
- We serve single point of communication for the different projects.
- Biofact has successfully managed projects for all the clients.
- Every project is assigned to a team including Project Manager, Site Manager, Quality Manager, Clinical trail assistant, Research coordinators who are experienced in all aspects of handling a successful clinical trail.
- The company have a team-oriented approach, each, member experienced throughout every step of the process, to provide client with a high quality service.
Our Sites
- Maharashtra: Mumbai, Pune, Nashik, Nagpur, Barshi, Aurangabad, Kolhapur, Ahmednagar, Miraj, Amravati, Solapur, Kopargaon, Karad, Nandurbar, Sangli, Baramati, Loni, Jalgaon, Vardha.
- Madhya Pradesh: Bhopal, Indore, Jabalpur
- Gujarat: Ahmadabad, Vadodara, Rajkot, Surat, Karamsad.
- Rajasthan: Jaipur, Jodhpur, Udaipur
- Uttar Pradesh: Lucknow, Bareilly, Meerut, Noida.
- Bihar: Patna
- Punjab - Haryana: Chandigarh, Ludhiana, Jalandhar, Panchkula, Hissar.
- Karnataka: Bangalore, Belgaum
- Tamil Nadu: Chennai, Madurai, Vellore
- Andhra Pradesh: Tirupathi, Vijayawada, Visakhapatnam, Guntur, Vijayawada.
- Telengana: Hyderabad, Secunderabad, Warangal, Karimnagar, Nizamabad, Mahbubnagar.
- Orissa: Cuttack, Bhubaneswar
- West Bengal: Kolkata, Uttarpara
- Delhi & Goa: Not applicable
Our Services
- Complete site feasibility with infrastructure and as per protocol-specific requirements and specifications.
- Site Pre - Auditing.
- ICH- GCP Trained staff availability.
- Well equipment LAB facilities (-20°C, -70°C Defreeze cold centrifuge)
- Initiating Budget negotiation and clinical tail agreement (CTA).
- Initiating and submitting for Ethics committee approval as per guidelines, backed by follow-up and query resolution, if required clinical trail material, management and coordination patientscreening.
- Proper storage of the CTM has been ensured.
- The team members are prepared on reporting of AEs/SAEs, regulations/guidelines, inclusion/exclusion criteria
- Assemble/calibrate all equipment required to conduct study – related procedures.
- Assisting investigators in the informed consent process.
- Coordination and management of laboratory samples, courier and follow-ups of lab reports.
- IXRS, IWRS and IVRS for patient's randomization in randomized studies
- Investigational Drug/product management and dispensing, temperature monitoring and accountability.
- Patient Recruitment & Retention.
- Preparation, attendance and follow-up of monitoring.
- Completing CRF entry with minimal error
- Preparation for of Audit.
- Trial Close-out: Preparation and follow-up.
- All Biofact CRCs are trained to log both Paper CRF and E-CRF.
MEDICAL WRITING SERVICES
1. Clinical
- Clinical Study Reports (CSRs)
- Protocols and Protocol Amendments
- Investigator’s Brochures (IBs) and IB Updates
- Regulatory Submission Summary Documents (IND/NDA/MAA/CTA)
- Responses to Questions (RTQs)/Regulatory Responses (across multiple health authorities)
- Pre-Meeting Packages/Briefing Packages
- Orphan Drug Applications
- Pediatric Investigation Plans
- Pediatric Study Plans (including waivers)
- Health Outcomes Economics/Real World Evidence Documents
- Fast Track Designation
- Orphan Drug Designation (ODD) Application/Annual Reports
- Immunogenicity Reports
- Ethnic Sensitivity Reports
- Conditional Marketing Authorization (CMA)
2. Safety
- Development Safety Update Reports (DSURs)
- Periodic Benefit Risk and Evaluation Reports (PBRERs)
- Periodic Safety Update Reports (PSURs)
- Periodic Adverse Drug Experience Reports (PADERs)
- Risk Management Plans
- Assessment of Benefit-Risk (ABR)
- Annual Reports
- Patient Safety Narratives
- Product labels, company core data sheet (CCDS)
- A summary of product characteristics (SmPC)
- The United States prescribing information (USPI)
3. Diagnostics
- Protocol Proposals
- Clinical Validation Plan/Clinical Performance Plan
- Clinical Validation Report/Clinical Performance Report
- Clinical Study Protocols (CSPs)
- Clinical Study Reports (CSRs)
- Intended Use Statements
- Performance Evaluation Plan (PEP)
- Performance Evaluation Report (PER)
- State-of-the-Art Determination (SOTA)
- Scientific Validity Report (SVR)
- Medical Assessment
- Medical Opinion Documents
4. Devices
- Clinical Evaluation Plans (CEPs)
- Clinical Evaluation Reports (CERs)
- Investigational Device Exemption (IDE)
5. Publications
- Scientific Manuscripts/Abstracts - Strategic publication plans, manuscripts, posters, abstracts, and speaker decks
- Posters
- Literature Reviews/Summaries
- Oral Presentation
6. Other Scientific Documents
- Plain Language Documents (protocol synopses, results summaries)
- Informed Consent Forms (ICFs)
- Regulatory White Papers
- Consumer Health Product Documents
7. CMC writing: Chemistry, manufacturing, and controls (CMC) writing, that includes information related to drug substance, drug product, and overall quality summaries.
8. Medical Writing for Marketing
- Web content
- Web pages
- Blog pages
- Articles
- Brochures
- Webinars
- Social media posts
- Video scripts
- White papers
- Copywriting
- Newsletters
9. Regulatory Medical Writing
10. Educational Material
Our LAB
- Biofact has the capability to provide laboratory services for conduct trails across various therapeutic segments.
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The Laboratory promises to deliver accurate results in the shortest possible turn around time.
- CAP, BIO RAD
- ISO 9001-200 Certified LAB
- Fully automated 24 x 7 LAB
- CDSCO, 21 CRF PART 210 & 211, ISO 17025 Compliant laboratory.
- Fully integrated lab information system.
Why Choose Us
- Customer centric SMO with Dynamic Leadership
- Services provider with confidentiality and impartiality
- Quality Service with regulatory compliance
- Fast Turn Around Time (TAT)
- Team of Experienced, Competent and Qualified Scientists
- Well defined procedures as per global standards