Clinical Research

At MEDCO, our mission is to help provide our world wide clients with
cost-effective research services and facilities to enable them to bring life saving,
best in class drugs and medical equipment to market in the
shortest possible time and always within their budget.

The people at Medco are highly experienced professionals in the field of clinical research and trials. Whether your company is a small biotech with limited resources or a large multinational pharmaceutical or medical devices company, Medco can design and conduct safety trials that will meet or exceed every regulatory and scientific benchmark without ever compromising our company’s high ethical standards.

Medco’s clinical research division offers a range of services to help companies shorten the time to market of their new products. Our goal is to not only to help reduce the time and risk, and the associated costs in conducting clinical trials but to do so with unsurpassed quality, efficiency and speed while simultaneously ensuring the health and safety of the trial participants.

Besides providing our clinical trial customers with accuracy and quality, Medco strives to provide you with total confidentiality. Our processes are so designed that all your information is always 100% safe and secure with us. We comply by all International standards of Safety and Confidentiality.

A peek into how Medco delivers Results

Cognizant of the fact that our customers need their clinical trials designed and conducted and the results tabulated in a streamlined fashion to avoid unnecessary and expensive delays, we at Medco assign an independent, highly qualified Project Manager on every single trial program. This Project Manager with hands on experience in clinical and regulatory regimen is trained to take your project to heart and is 100% focused and dedicated to ensure that all of your needs are met to your complete satisfaction. That means developing a sense of commitment, ownership and pride in overcoming the challenges that inevitably develop during any complex project. It means getting the job done, whatever it takes.

The Process

We understand that 'time is money', therefore, Medco’s professionally trained staff will assist you in successfully navigating your company’s clinical trial program through every step of the highly complex drug development and regulatory process; from the submission of the initial application to the final coveted nod of approval. Our services include:

Strategic Planning

Plan strategy to deal with regulatory agency
Product development strategy
GAP analysis and Corrective action plan
Dossier preparation
Submission planning for all stages
Creation of operational link between regulatory agencies and sponsor
Assessment of issues, their analysis and final resolution

Submission and Tracking

Filing of all submission
Submissions’ tracking
Query resolution

Project Management

Our project management team will provide the required leadership to plan and integrate cross-functional activity to ensure that the projects are on time and within budget with a devotion to quality assurance throughout.

Recruit investigators through our direct contact and from our in-house investigator database:

Train investigators and site personnel
Patient recruitment and retention
Prepare clinical development plan
Randomization, repackaging, coding and labeling of investigational drugs
Schedule monitoring activities
Arrange and conduct steering committee meetings
Provide clean and locked data
Archiving
Study site support
Site feasibility studies

Medical Writing

Our medical writers have a strong academic, pharmaceutical, and biotechnology industry background and can help you prepare clear, concise, and high quality:

Investigator Brochure
Protocol
Case Report Form
Patient information leaflets for clinical trials and package inserts
Informed Consent Form
Safety data reports
Statistical analysis plan
Medical translation services
Regulatory submissions
Final Report

Study Site Support

We provide a wide range of clinical research services at the study site to meet quality and ICH-GCP compliance at the highest level

Site/Investigator identification and selection
Site initiation
Medical monitoring
Study close-out
Query Management

Safety Surveillance

Each clinical research team is available 24/7 via a specially dedicated phone line to take medically related questions or for the of reporting adverse events. Safety surveillance and reporting services include:

Review of Protocol, Investigator Brochure, Informed Consent Form, and Case Report Form
Safety monitoring
Emergency Un-blinding in case of a serious adverse event
Serious Adverse Event collection, evaluation, classification and reporting to Central IRB/ Sponsor/ Regulatory authorities
Developing safety database
Periodic safety update reports
Organize IDMB

Clinical Compliance

Clinical compliance services include audit service for Investigator sites as per protocol, SOPs, ICH-GCP and other regulatory requirements

ICH-GCP compliance review
IRB audits
On-site investigator audits
Drug accountability reviews
Clinical compliance per protocol

Data Management and Processing

Medco will provide sophisticated solutions that will help meet the challenge of data collection and management through Oracle ClinicalÆ version 4.5. Our solutions are complete and robust with the integrated Remote Data Capture allowing companies to rethink some of the traditional data management processes.

At Medco, Oracle ClinicalÆ automates study design, data collection, data management and regulatory submissions, using an architecture that can scale to handle hundreds of studies per year which in turn will help our customers to bring medical products to market faster and at a lower cost. Our fully integrated Clinical Data
Management offers solutions to the collection and management of data irrespective of from where in the world the data is gathered.

Medco guarantees its clients that we will always provide you with clean, accurate data in an expedited fashion to help you stay within budget. Medco has strong systems with SOPs to handle all modes of data capture – Paper, Fax and Web. Our professional staff has tremendous experience in handling disparate data management solutions.

Our data backup and disaster recovery systems takes the worry out of data collection and storage and our 24/7 customer access to our data management team ensures that our customer enjoys unrivaled assistance during the conduct of your trial. The security protocol with robust, state of the art, firewall protection that requires multiple levels of authorizations with complete audit trail of the activities from the initiation of the trial up until its final conclusion further guarantees our customers that their valuable data is safe from unauthorized access. Furthermore, our systems require that ALL transactions occur only through secured internet connections using SSL 128 bit encryption with very robust intrusion detection systems, whereby insuring the safety and integrity of the transferred data.

Medco can also offer customized reports at predetermined intervals so that you may constantly be able to monitor the pulse of the trials.

Our services include:

Database & eCRF design
CRF management
Double data entry
Electronic data capture
Web and Fax based receipt of CRF
Data validation and review
Medical coding using MedDRA
SASÆ programming
Data processing and migration
Data generation for analysis
Trial scalability and site flexibility
Transparent and seamless data conversion
Randomization and trial supply management for multi-center trials

Statistical Analysis

Medco’s in-house biostatisticians are also available, on a contract basis, to help provide our customers with crucial analytical expertise for coordinating clinical trials. Our statisticians can be involved in your trials from the initial design stage to analyze all of the data generated from your clinical trials for the final manuscript publication and beyond. We strive to deliver to you clean, accurate and locked database on time.

Our bio statistical services include:

Protocol Preparation

Development of study design:
Sample size/statistical power determination
Formulation of statistical analysis section of protocols.
Describe both interim and final analysis strategies

Consultation/Planning:
Consult on statistical problems Prepare for discussions with regulatory agencies
Hold planning sessions with customers to interpret or clarify analyses

Report Preparation:
Prepare integrated clinical/statistical reports
Design tables and graphics
Summary of all statistical methodologies and results

Submission Support:
Support submissions to regulatory agencies
Make formal presentations to regulatory agencies at advisory committee meetings

Oracle Clinicals® Advantages & Features

Advantages:

Fully integrated for global data management

RDE enabled for entry from anywhere in the world

High level security

Incorruptible database setup

Complete audit trail mechanism, ready for data audit by regulatory agencies

Possible enablement to global lab data capturing

Data export to SASÆ

21CFR Part 11 compliant

Disaster recovery mechanism in place through backups at Medco’s US data warehouse.

Features

Integrated subsystems for

Study design

Study data definition

Study conduct

Analysis and reporting

Laboratory reference ranges

Powerful built-in discrepancy management system providing total management of each discrepancy from creation through to resolution.

Full audit trails on data definitions, patient data, and discrepancies

Flexible Batch Data Load

Integrated randomization

Create any number of data snapshots for interim analysis during normal data processing

Query the data through an online query facility

Include locked or frozen data, as well as discrepancy status information, in extracted data

Develop detailed visit schedule specification and tracking, including the identification of missing and late Case Report Forms (CRFs)

Manage and track treatment blind breaks

Track patient availability and withdrawal information

Total Security to the database is ensured from external access/corruption via a robust firewall

Highly secured data management premises with fully controlled Proximity Access System

Reliable backup and restore policy that keeps the data safe. It reduces the time required to back up and recover mission-critical data

Compliance of capabilities include management of user accounts, configurable security, automatic recording of audit trails for both patient data and metadata, preservation of data during system upgrades, electronic signatures, etc.

Information Technology (IT) Services

Medco’s IT team provides technology support during each and every aspect of your company’s clinical research program, be that in managing solutions on site or providing critical backup support. We at Medco have the required technology and experience to meet and exceed the most stringent global standards. The wide array of services offered by Medco helps our customer dedicated teams in meeting the challenges inherent in the conduct of today’s very challenging and complex clinical trial programs. We offer:

• 24 x 7 Help desk

• Clinical trial management support systems

• Imaging database support Services

• Global data integration

• Web portal management

• Document management

• Site setup and support services

• IVRS